Pub Date : 2017-10-01DOI: 10.4103/2542-3932.217493
W. Qian, Wei Zhang, Hao Jin, Y. Zhu, Yu Zou
Background and objectives: Repair of the damaged skull is necessary after decompressive craniectomy. Previously used autologous bone, allogeneic bone, and organic material are associated with the risk of an unsatisfactory cosmetic outcome and infection. Titanium mesh is an ideal material for cranioplasty. Digital three-dimensional shaping of titanium mesh allows it to perfectly match the skull defect and can restore the anatomic appearance of the defective area. Design: Retrospective case analysis. Methods: We analyzed the surgical and follow-up data of 38 patients with skull defects who underwent subtemporal repair using three-dimensional shaping of a titanium plate at the Department of Neurosurgery, Wujiang Hospital (The First People's Hospital of Wujiang District), Nantong University, China, from January 2015 to December 2016. Outcome measures: The primary outcome measure was the incidence of complications within 12 months after surgery. The secondary outcome measures were the Glasgow outcome scale score, Karnofsky performance scale score, National Institutes of Health stroke scale score, and skull computed tomography scan results at 1, 6, 12, 18, and 24 months after repair. Partial results have been obtained for 38 patients who have been followed up for 6 to 24 months. No complications or adverse reactions occurred. Skull computed tomography scan results revealed that the titanium mesh and nail were well fixed, the skull shape was symmetrical, and no subcutaneous effusion or intracranial hemorrhage occurred. Discussion: Complications, neurological function, and imaging findings in patients with frontotemporal skull defects provide an experimental basis for three-dimensional shaping of titanium plates in subtemporal repair of frontotemporal defects. Ethics and dissemination: The study design was completed in May 2017. The protocols had been approved by the Ethics Committee of The First People's Hospital of Wujiang District in June 2017. This trial was registered in October 2017. Data of patients, who were treated from January 2015 to December 2016, were analyzed in June 2017. Data analysis will be finished in December 2017. The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (identifier: ChiCTR-IOC-17012947). All data collection and analysis are currently ongoing.
{"title":"Safety and efficacy of three-dimensional shaping of titanium plate in subtemporal repair of skull defects: study protocol for a data analysis of 38 patients","authors":"W. Qian, Wei Zhang, Hao Jin, Y. Zhu, Yu Zou","doi":"10.4103/2542-3932.217493","DOIUrl":"https://doi.org/10.4103/2542-3932.217493","url":null,"abstract":"Background and objectives: Repair of the damaged skull is necessary after decompressive craniectomy. Previously used autologous bone, allogeneic bone, and organic material are associated with the risk of an unsatisfactory cosmetic outcome and infection. Titanium mesh is an ideal material for cranioplasty. Digital three-dimensional shaping of titanium mesh allows it to perfectly match the skull defect and can restore the anatomic appearance of the defective area. Design: Retrospective case analysis. Methods: We analyzed the surgical and follow-up data of 38 patients with skull defects who underwent subtemporal repair using three-dimensional shaping of a titanium plate at the Department of Neurosurgery, Wujiang Hospital (The First People's Hospital of Wujiang District), Nantong University, China, from January 2015 to December 2016. Outcome measures: The primary outcome measure was the incidence of complications within 12 months after surgery. The secondary outcome measures were the Glasgow outcome scale score, Karnofsky performance scale score, National Institutes of Health stroke scale score, and skull computed tomography scan results at 1, 6, 12, 18, and 24 months after repair. Partial results have been obtained for 38 patients who have been followed up for 6 to 24 months. No complications or adverse reactions occurred. Skull computed tomography scan results revealed that the titanium mesh and nail were well fixed, the skull shape was symmetrical, and no subcutaneous effusion or intracranial hemorrhage occurred. Discussion: Complications, neurological function, and imaging findings in patients with frontotemporal skull defects provide an experimental basis for three-dimensional shaping of titanium plates in subtemporal repair of frontotemporal defects. Ethics and dissemination: The study design was completed in May 2017. The protocols had been approved by the Ethics Committee of The First People's Hospital of Wujiang District in June 2017. This trial was registered in October 2017. Data of patients, who were treated from January 2015 to December 2016, were analyzed in June 2017. Data analysis will be finished in December 2017. The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (identifier: ChiCTR-IOC-17012947). All data collection and analysis are currently ongoing.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86018217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-07-01DOI: 10.4103/2542-3932.211591
Mo Li, Jihui Lyu, Yi Zhang, M. Gao, Yanlun Gao, Mengnan Cui
Background and objectives: Patients with Alzheimer's disease (AD) often experience abnormal mental and behavioral symptoms. Clinically, antipsychotic and antidepressant drugs are often used to control behavioral and psychological symptoms of dementia (BPSD), but these drugs have anticholinergic and vertebral effects and have the risk of affecting metabolic diseases and increasing stroke mortality. Infra-low-frequency transcranial magnetic stimulation (ILF-TMS) can regulate the electrical activity of each transmitter, modulating the physiological function of the transmitter to achieve therapeutic effects. Thus, this randomized parallel-design controlled trial examined the use of ILF-TMS as a treatment for BPSD in patients with AD. The study aims to evaluate the efficacy and safety of ILF-TMS in patients with AD who also show BPSD following conventional drug therapy. Design: This is a randomized parallel-design controlled trial. Methods: AD patients with BPSD in the Beijing Geriatric Hospital, China will be randomized into control (sham stimulation) and stimulation groups (n = 50/group). Eight patients from each group will participate in a preliminary experiment, and the remaining 42 will participate in the trial. For the stimulation group, along with conventional drug therapy, participants will be exposed to ILF-TMS (stimulation frequency < 0.2 Hz; total magnetic field strength, 0.1–40 mT) for 20 minutes per exposure 5 times/week for 8 consecutive weeks. Patients in the control group will undergo sham stimulation and conventional drug therapy. Outcome measures: The primary outcome measure will be neuropsychiatric inventory score differences observed before treatment, at 4 and 8 weeks of treatment, and 4 weeks after treatment. The secondary outcome measures will be Mini-Mental State Examination and Barthel Index scores before treatment, at 4 and 8 weeks of treatment, and 4 weeks after treatment. Discussion: The trial is intended to explore a potential new approach for the treatment of behavioral and psychiatric symptoms in patients with AD. This will help to improve poor mental symptoms and the quality of life and reduce psychological and social burdens. Ethics and dissemination: The protocols have been approved by the ethics committee of Beijing Geriatric Hospital of China (approval No. 2016-021) on November 11th, 2016. Study design completed October 2016; ethical approval received November 2016; clinical registration conducted January 2017; patient recruitment began January 2017. Each patient will receive 8 weeks of treatment and 4 weeks of follow-up. Follow-up will be completed December 2017, and data analysis will be completed December 2018. Results will be disseminated through presentations at scientific meetings and publications in peer-reviewed journals. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-INR-17010487) on January 20th, 2017.
{"title":"Efficacy and safety of infra-low-frequency transcranial magnetic stimulation in Alzheimer's disease patients with behavioral and psychological symptoms of dementia: study protocol for a randomized parallel-design controlled trial","authors":"Mo Li, Jihui Lyu, Yi Zhang, M. Gao, Yanlun Gao, Mengnan Cui","doi":"10.4103/2542-3932.211591","DOIUrl":"https://doi.org/10.4103/2542-3932.211591","url":null,"abstract":"Background and objectives: Patients with Alzheimer's disease (AD) often experience abnormal mental and behavioral symptoms. Clinically, antipsychotic and antidepressant drugs are often used to control behavioral and psychological symptoms of dementia (BPSD), but these drugs have anticholinergic and vertebral effects and have the risk of affecting metabolic diseases and increasing stroke mortality. Infra-low-frequency transcranial magnetic stimulation (ILF-TMS) can regulate the electrical activity of each transmitter, modulating the physiological function of the transmitter to achieve therapeutic effects. Thus, this randomized parallel-design controlled trial examined the use of ILF-TMS as a treatment for BPSD in patients with AD. The study aims to evaluate the efficacy and safety of ILF-TMS in patients with AD who also show BPSD following conventional drug therapy. Design: This is a randomized parallel-design controlled trial. Methods: AD patients with BPSD in the Beijing Geriatric Hospital, China will be randomized into control (sham stimulation) and stimulation groups (n = 50/group). Eight patients from each group will participate in a preliminary experiment, and the remaining 42 will participate in the trial. For the stimulation group, along with conventional drug therapy, participants will be exposed to ILF-TMS (stimulation frequency < 0.2 Hz; total magnetic field strength, 0.1–40 mT) for 20 minutes per exposure 5 times/week for 8 consecutive weeks. Patients in the control group will undergo sham stimulation and conventional drug therapy. Outcome measures: The primary outcome measure will be neuropsychiatric inventory score differences observed before treatment, at 4 and 8 weeks of treatment, and 4 weeks after treatment. The secondary outcome measures will be Mini-Mental State Examination and Barthel Index scores before treatment, at 4 and 8 weeks of treatment, and 4 weeks after treatment. Discussion: The trial is intended to explore a potential new approach for the treatment of behavioral and psychiatric symptoms in patients with AD. This will help to improve poor mental symptoms and the quality of life and reduce psychological and social burdens. Ethics and dissemination: The protocols have been approved by the ethics committee of Beijing Geriatric Hospital of China (approval No. 2016-021) on November 11th, 2016. Study design completed October 2016; ethical approval received November 2016; clinical registration conducted January 2017; patient recruitment began January 2017. Each patient will receive 8 weeks of treatment and 4 weeks of follow-up. Follow-up will be completed December 2017, and data analysis will be completed December 2018. Results will be disseminated through presentations at scientific meetings and publications in peer-reviewed journals. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-INR-17010487) on January 20th, 2017.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84192078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-07-01DOI: 10.4103/2542-3932.211593
Xin-ran Ji, P. Tang, Ning Lu
Background and objectives: Spinal cord injury is an irreversible pathological process. Clinical findings in recent years have demonstrated that dural sac decompression can scavenge subdural hematoma and necrotic tissue, alleviate compression of the injured spinal cord, create a favorable microenvironment for regeneration of nerve repair, and promote recovery of neurological function. Therefore, this trial aims to examine the effect of dural sac decompression and spinal cord untethering for treating obsolete spinal cord injury. Design: This is a prospective, multicenter cohort study. Methods: Seventy-two patients with obsolete spinal cord injury from four clinical sites in China will be assigned to the trial group (n = 36) or control group (n = 36) according to therapeutic methods. Patients in the trial group will receive dural sac decompression and spinal cord untethering. Patients in the control group will undergo conservative treatment. All patients were followed up for 24 months. Outcome measures: The difference in American Spinal Injury Association scores between 3 months after treatment and before treatment is the primary outcome measure. For secondary outcome measures, the autonomic nervous scoring scale, the Visual Analog Scale, an electromyogram below the injured plane, somatosensory evoked potential, motor evoked potential, functional independent measure, the ID pain self-rating scale, the modified Ashworth Scale for grading spasticity, and the Penn Spasm Frequency Scale will be applied 3 months before treatment, and 1, 3, 6, 9, 12, 18, and 24 months after treatment. Urodynamic testing will be performed. Discussion: This trial is expected to provide an experimental basis for dural sac decompression and spinal cord untethering in patients with obsolete spinal cord injury. Ethics and dissemination: The protocols were approved by the Ethics Committee of Chinese PLA General Hospital on May 11th, 2016 (approval No. S2016-024-01). The study design was finished in April 2016. Recruitment of patients began in April 2017. Follow-up will be completed in December 2018. Data analysis will be completed in December 2019. The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-ONC-17010479) on January 19th, 2017. Recruitment of patients is ongoing.
{"title":"Dural sac decompression and spinal cord untethering for treating obsolete spinal cord injury: protocol for a prospective, multicenter cohort study","authors":"Xin-ran Ji, P. Tang, Ning Lu","doi":"10.4103/2542-3932.211593","DOIUrl":"https://doi.org/10.4103/2542-3932.211593","url":null,"abstract":"Background and objectives: Spinal cord injury is an irreversible pathological process. Clinical findings in recent years have demonstrated that dural sac decompression can scavenge subdural hematoma and necrotic tissue, alleviate compression of the injured spinal cord, create a favorable microenvironment for regeneration of nerve repair, and promote recovery of neurological function. Therefore, this trial aims to examine the effect of dural sac decompression and spinal cord untethering for treating obsolete spinal cord injury. Design: This is a prospective, multicenter cohort study. Methods: Seventy-two patients with obsolete spinal cord injury from four clinical sites in China will be assigned to the trial group (n = 36) or control group (n = 36) according to therapeutic methods. Patients in the trial group will receive dural sac decompression and spinal cord untethering. Patients in the control group will undergo conservative treatment. All patients were followed up for 24 months. Outcome measures: The difference in American Spinal Injury Association scores between 3 months after treatment and before treatment is the primary outcome measure. For secondary outcome measures, the autonomic nervous scoring scale, the Visual Analog Scale, an electromyogram below the injured plane, somatosensory evoked potential, motor evoked potential, functional independent measure, the ID pain self-rating scale, the modified Ashworth Scale for grading spasticity, and the Penn Spasm Frequency Scale will be applied 3 months before treatment, and 1, 3, 6, 9, 12, 18, and 24 months after treatment. Urodynamic testing will be performed. Discussion: This trial is expected to provide an experimental basis for dural sac decompression and spinal cord untethering in patients with obsolete spinal cord injury. Ethics and dissemination: The protocols were approved by the Ethics Committee of Chinese PLA General Hospital on May 11th, 2016 (approval No. S2016-024-01). The study design was finished in April 2016. Recruitment of patients began in April 2017. Follow-up will be completed in December 2018. Data analysis will be completed in December 2019. The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-ONC-17010479) on January 19th, 2017. Recruitment of patients is ongoing.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83599193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-07-01DOI: 10.4103/2542-3932.211589
B. Pradhan, I. Wainer, R. Moaddel, M. Torjman, Michael S. Goldberg, M. Sabia, Tapan Parikh, A. Pumariega
Background and objectives: Trauma memories lay at the core in etiopathogenesis of post-traumatic stress disorder (PTSD). Using pharmacological and cognitive behavioral treatments that specifically target trauma memories can improve the outcome. Ketamine has been shown to rapidly improve symptoms in PTSD and comorbid depression, but unfortunately these effects are short-lived. Trauma Interventions using Mindfulness Based Extinction and Reconsolidation (TIMBER) psychotherapy is a type of mindfulness based cognitive behavioral therapy that targets the trauma memories. TIMBER psychotherapy in combination with (R,S)-ketamine are increasingly used to treat PTSD and comorbid depression. This study aims to determine if the combination of (R,S)-ketamine chemotherapy and TIMBER psychotherapy would produce a positive synergistic response in patients with PTSD. Design: This is a randomized, placebo-controlled, cross-over clinical study. Methods: Because response to ketamine alone is short-lived, this study combined TIMBER with a single infusion of 0.5 mg/kg (R,S)-ketamine to sustain its therapeutic effects. Ten patients with chronic and refractory PTSD were randomly assigned to two groups (n = 5 each): TIMBER-K group patients received ketamine infusion in combination with 12 TIMBER sessions (3 sessions in the first week followed by 9 sessions conducted on a weekly basis) and TIMBER-P group patients received placebo (normal saline infusion) in combination with 12 TIMBER sessions. The patients in the TIMBER-P group were switched to those in the TIMBER-K group after they experienced a sustained relapse. Outcome measures: PTSD Checklist (PCL), Clinician Administered PTSD Scale for DSM-IV (CAPS), the 17-item Hamilton Rating Scale for Depression (Ham-D-17, clinician rated), Beck Anxiety Inventory (BAI), and Montreal Cognitive Assessment (MoCA) at baseline and 8 hours after infusion were used to investigate if ketamine selectively affected trauma memories leaving the general memory intact. The mindfulness interventions in TIMBER were personalized based on subject's scores on Assessment Scale for Mindfulness Interventions which was administered at baseline, and after 5 sessions and 9 sessions (completion) of TIMBER. In this study, scores on CAPS and PCL scales were the primary outcome measures. Results: In the acute phase trial ( first 3 months after infusion), nine out of 10 subjects showed robust response in primary outcome measures (PCL and CAPS scores for PTSD) and in the secondary outcome measures (Ham-D-17 and Beck Anxiety Inventory for depression and anxiety respectively) with a sustained response of 31.78 ± 18.29 days. The TIMBER-K group had a more sustained response (33 ± 22.98 days) compared to the TIMBER-P group (25 ± 16.8 days, P = 0.545). After switch from TIMBER-P group to TIMBER-K, patients experienced significantly prolonged response (49 vs. 25 days, P = 0.028). There were no intolerable side effects or dropouts during the 18-month follow-up period.
{"title":"Trauma Interventions using Mindfulness Based Extinction and Reconsolidation (TIMBER) psychotherapy prolong the therapeutic effects of single ketamine infusion on post-traumatic stress disorder and comorbid depression: a pilot randomized, placebo-controlled, crossover clinical trial","authors":"B. Pradhan, I. Wainer, R. Moaddel, M. Torjman, Michael S. Goldberg, M. Sabia, Tapan Parikh, A. Pumariega","doi":"10.4103/2542-3932.211589","DOIUrl":"https://doi.org/10.4103/2542-3932.211589","url":null,"abstract":"Background and objectives: Trauma memories lay at the core in etiopathogenesis of post-traumatic stress disorder (PTSD). Using pharmacological and cognitive behavioral treatments that specifically target trauma memories can improve the outcome. Ketamine has been shown to rapidly improve symptoms in PTSD and comorbid depression, but unfortunately these effects are short-lived. Trauma Interventions using Mindfulness Based Extinction and Reconsolidation (TIMBER) psychotherapy is a type of mindfulness based cognitive behavioral therapy that targets the trauma memories. TIMBER psychotherapy in combination with (R,S)-ketamine are increasingly used to treat PTSD and comorbid depression. This study aims to determine if the combination of (R,S)-ketamine chemotherapy and TIMBER psychotherapy would produce a positive synergistic response in patients with PTSD. Design: This is a randomized, placebo-controlled, cross-over clinical study. Methods: Because response to ketamine alone is short-lived, this study combined TIMBER with a single infusion of 0.5 mg/kg (R,S)-ketamine to sustain its therapeutic effects. Ten patients with chronic and refractory PTSD were randomly assigned to two groups (n = 5 each): TIMBER-K group patients received ketamine infusion in combination with 12 TIMBER sessions (3 sessions in the first week followed by 9 sessions conducted on a weekly basis) and TIMBER-P group patients received placebo (normal saline infusion) in combination with 12 TIMBER sessions. The patients in the TIMBER-P group were switched to those in the TIMBER-K group after they experienced a sustained relapse. Outcome measures: PTSD Checklist (PCL), Clinician Administered PTSD Scale for DSM-IV (CAPS), the 17-item Hamilton Rating Scale for Depression (Ham-D-17, clinician rated), Beck Anxiety Inventory (BAI), and Montreal Cognitive Assessment (MoCA) at baseline and 8 hours after infusion were used to investigate if ketamine selectively affected trauma memories leaving the general memory intact. The mindfulness interventions in TIMBER were personalized based on subject's scores on Assessment Scale for Mindfulness Interventions which was administered at baseline, and after 5 sessions and 9 sessions (completion) of TIMBER. In this study, scores on CAPS and PCL scales were the primary outcome measures. Results: In the acute phase trial ( first 3 months after infusion), nine out of 10 subjects showed robust response in primary outcome measures (PCL and CAPS scores for PTSD) and in the secondary outcome measures (Ham-D-17 and Beck Anxiety Inventory for depression and anxiety respectively) with a sustained response of 31.78 ± 18.29 days. The TIMBER-K group had a more sustained response (33 ± 22.98 days) compared to the TIMBER-P group (25 ± 16.8 days, P = 0.545). After switch from TIMBER-P group to TIMBER-K, patients experienced significantly prolonged response (49 vs. 25 days, P = 0.028). There were no intolerable side effects or dropouts during the 18-month follow-up period. ","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75137107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-07-01DOI: 10.4103/2542-3932.211592
Qian-qian Sun, D. Xie, J. Tao, T. Yan, Huihua Liu, Qiang Li, Bing-tian Zhang, Junmei Xu, Xiao-Kuo He
Background and objectives: Effect of conventional rehabilitation methods is still not satisfactory to patients with post-stroke hemiplegia. Studies have demonstrated that acupuncture can improve motor function in stroke patients. Quchi (LI11) and Zusanli (ST36) are most commonly used in the treatment of post-stroke hemiplegia. We will observe the effects of acupuncture on neural plasticity in patients with post-stroke hemiplegia after acupuncture at Quchi and Zusanli. Design: This is a prospective multicenter randomized parallel controlled trial. Methods: The trial will be conducted in Shiyan Taihe Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, and the Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine, China. A total of 210 patients with post-stroke hemiplegia will be randomized into an acupuncture priority group, acupuncture delay group, sham acupuncture priority group, and sham acupuncture delay group (n = 45). On the basis of basic treatment and conventional rehabilitation training, acupuncture (acupuncture priority group and acupuncture delay group) or sham acupuncture (sham acupuncture priority group and sham acupuncture delay group) at Quchi and Zusanli will be performed 15 minutes before conventional rehabilitation training (priority) or 15 minutes after conventional rehabilitation training (delay), once a day for 30 minutes, 5 days per week, for 8 consecutive weeks. Patients will undergo one follow-up assessment for 4 months. Outcome measures: The primary outcome measure will be the efficacy of the treatment after the 8-week period, stated as a percentage calculated by taking the difference between the final simplified Fugl-Meyer motor function score and the baseline score, and dividing this value by the baseline score. Brunnstrom stage classification, Barthel Index score, and electrophysiological changes will serve as secondary outcome measures. Discussion: We hope to produce new information leading to improved timing for the combined use of acupuncture and modern rehabilitation therapy, and identify the effects of acupuncture at Quchi and Zusanli on cortical excitability and plasticity. Ethics and dissemination: The protocols have been approved by the Ethics Committee of Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) of China (approval No. 2014001-2) on August 26th, 2013. We will submit the trial's results for presentation at international scientific meetings and to peer-reviewed journals. The study design was completed in July 2013. Ethical approval was received in August 2013. Clinical registration was conducted in January–February 2017. Patient recruitment began in March 2017. The follow-up will be completed in September 2018. Data analysis will be conducted in June 2019. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-IPR-17010490) on January 20th, 2017, and in the Acupuncture-Moxibustion Clinical
{"title":"Acupuncture regulation promotes functional recovery in patients with post-stroke hemiplegia: study protocol for a multicenter randomized parallel controlled trial","authors":"Qian-qian Sun, D. Xie, J. Tao, T. Yan, Huihua Liu, Qiang Li, Bing-tian Zhang, Junmei Xu, Xiao-Kuo He","doi":"10.4103/2542-3932.211592","DOIUrl":"https://doi.org/10.4103/2542-3932.211592","url":null,"abstract":"Background and objectives: Effect of conventional rehabilitation methods is still not satisfactory to patients with post-stroke hemiplegia. Studies have demonstrated that acupuncture can improve motor function in stroke patients. Quchi (LI11) and Zusanli (ST36) are most commonly used in the treatment of post-stroke hemiplegia. We will observe the effects of acupuncture on neural plasticity in patients with post-stroke hemiplegia after acupuncture at Quchi and Zusanli. Design: This is a prospective multicenter randomized parallel controlled trial. Methods: The trial will be conducted in Shiyan Taihe Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, and the Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine, China. A total of 210 patients with post-stroke hemiplegia will be randomized into an acupuncture priority group, acupuncture delay group, sham acupuncture priority group, and sham acupuncture delay group (n = 45). On the basis of basic treatment and conventional rehabilitation training, acupuncture (acupuncture priority group and acupuncture delay group) or sham acupuncture (sham acupuncture priority group and sham acupuncture delay group) at Quchi and Zusanli will be performed 15 minutes before conventional rehabilitation training (priority) or 15 minutes after conventional rehabilitation training (delay), once a day for 30 minutes, 5 days per week, for 8 consecutive weeks. Patients will undergo one follow-up assessment for 4 months. Outcome measures: The primary outcome measure will be the efficacy of the treatment after the 8-week period, stated as a percentage calculated by taking the difference between the final simplified Fugl-Meyer motor function score and the baseline score, and dividing this value by the baseline score. Brunnstrom stage classification, Barthel Index score, and electrophysiological changes will serve as secondary outcome measures. Discussion: We hope to produce new information leading to improved timing for the combined use of acupuncture and modern rehabilitation therapy, and identify the effects of acupuncture at Quchi and Zusanli on cortical excitability and plasticity. Ethics and dissemination: The protocols have been approved by the Ethics Committee of Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) of China (approval No. 2014001-2) on August 26th, 2013. We will submit the trial's results for presentation at international scientific meetings and to peer-reviewed journals. The study design was completed in July 2013. Ethical approval was received in August 2013. Clinical registration was conducted in January–February 2017. Patient recruitment began in March 2017. The follow-up will be completed in September 2018. Data analysis will be conducted in June 2019. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-IPR-17010490) on January 20th, 2017, and in the Acupuncture-Moxibustion Clinical","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82058192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-07-01DOI: 10.4103/2542-3932.211590
R. Grigolon, Q. Cordeiro, A. Trevizol
Background and objectives: Obesity is one of the most important diseases around the world and it is an increasing issue for public health. Food craving is a usually noticeable symptom that is described as a “strong desire or urge to eat”. The vagus nerve and its relations to the neurocircuitry of the reward system play essential roles in the regulation of food intake. Transcutaneous stimulation of the auricular branch of the vagus nerve (taVNS) was previously described for its neuromodulatory effects in neuropsychiatric disorder. This study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation on food craving in patients with obesity. Design: A two-arm, triple-blinded, randomized, sham-controlled phase II trial. Methods: This will be conducted at The Center for Neuromodulation Studies, Federal University of São Paulo, Brazil. Fifty-four subjects with food craving will be assigned to either: 1) a 10-session treatment protocol of real taVNS, or 2) a 10-session treatment protocol of sham taVNS. Participants will be evaluated for outcome measures before and after intervention, with a follow-up visit of 30 days after the end of treatment. Outcome measures: The primary outcome measure will be changes in food craving evaluated by Food Craving Questionnaire-State and Trait. The secondary outcomes will be improvement of anthropometric measures (body mass index and hip/waist ratio), metabolic profile (blood pressure, cholesterol and triglycerides levels and fasting glucose), dietary habits (dietary diary and Food Craving Inventory) and depressive symptoms (Inventory for Depressive Symptoms), and quantitative electroencephalography and heart rate variability. Discussion: To the best of our knowledge, there are no studies on the effects of taVNS on alleviating craving symptoms. Given the epidemiological situation and economic and social burdens, the possibility of modulating the reward system neurocircuitry through the vagus nerve using an easy-to-operate, low-cost, safe and potential at-home use method represents a breakthrough in the treatment of obesity. Ethics and dissemination: The study will be approved by the ethics committee from the Federal University of São Paulo, Brazil. Patient recruitment will initiate in October 2017; analysis of primary outcome measures will be completed in October 2018 and the study will be finished in October 2019. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration: ClinicalTrials.gov identifier: NCT03217929; registered on July 11th, 2017.
{"title":"Transcutaneous auricular vagus nerve stimulation for food craving: study protocol for a phase II randomized, sham-controlled clinical trial","authors":"R. Grigolon, Q. Cordeiro, A. Trevizol","doi":"10.4103/2542-3932.211590","DOIUrl":"https://doi.org/10.4103/2542-3932.211590","url":null,"abstract":"Background and objectives: Obesity is one of the most important diseases around the world and it is an increasing issue for public health. Food craving is a usually noticeable symptom that is described as a “strong desire or urge to eat”. The vagus nerve and its relations to the neurocircuitry of the reward system play essential roles in the regulation of food intake. Transcutaneous stimulation of the auricular branch of the vagus nerve (taVNS) was previously described for its neuromodulatory effects in neuropsychiatric disorder. This study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation on food craving in patients with obesity. Design: A two-arm, triple-blinded, randomized, sham-controlled phase II trial. Methods: This will be conducted at The Center for Neuromodulation Studies, Federal University of São Paulo, Brazil. Fifty-four subjects with food craving will be assigned to either: 1) a 10-session treatment protocol of real taVNS, or 2) a 10-session treatment protocol of sham taVNS. Participants will be evaluated for outcome measures before and after intervention, with a follow-up visit of 30 days after the end of treatment. Outcome measures: The primary outcome measure will be changes in food craving evaluated by Food Craving Questionnaire-State and Trait. The secondary outcomes will be improvement of anthropometric measures (body mass index and hip/waist ratio), metabolic profile (blood pressure, cholesterol and triglycerides levels and fasting glucose), dietary habits (dietary diary and Food Craving Inventory) and depressive symptoms (Inventory for Depressive Symptoms), and quantitative electroencephalography and heart rate variability. Discussion: To the best of our knowledge, there are no studies on the effects of taVNS on alleviating craving symptoms. Given the epidemiological situation and economic and social burdens, the possibility of modulating the reward system neurocircuitry through the vagus nerve using an easy-to-operate, low-cost, safe and potential at-home use method represents a breakthrough in the treatment of obesity. Ethics and dissemination: The study will be approved by the ethics committee from the Federal University of São Paulo, Brazil. Patient recruitment will initiate in October 2017; analysis of primary outcome measures will be completed in October 2018 and the study will be finished in October 2019. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration: ClinicalTrials.gov identifier: NCT03217929; registered on July 11th, 2017.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90690629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-04-01DOI: 10.4103/2542-3932.205193
P. Chand, F. Jan, Sidra Kaleem, Mohammad Tahir Yousafzai, S. Ibrahim
Background: Guillain-Barre syndrome (GBS) is an acquired inflammatory polyneuropathy characterized by rapidly progressive symmetrical flaccid limb weakness and areflexia. Here, we aimed to describe GBS on the basis of clinical features using Hughes scoring system (HSS) in children. Methods: We conducted a descriptive study, retrieving medical records of children between 2–16 years old admitted with GBS during January 2011–December 2013 at Aga Khan University Hospital, Karachi. Information on demographics, predisposing factors of GBS, clinical features at presentation, investigations, managements, short- and long-term outcomes were recorded on data extraction sheet. Ethical approval was obtained before data collection. Results: Totally 31 children with GBS (21 males) were admitted during the study period. The mean age was 6.7 years. Thirteen cases were seen in summer (January–October) followed by 11 in spring (March–May) and 7 in winter (November–February). Preceding illnesses including upper respiratory tract infections in 15 and diarrhea was seen in 4 patients. None of the patients had history of prior immunization. The nerve conduction study/electromyography showed acute inflammatory demyelinating polyradiculoneuropathy in 18 (58%), acute motor axonal neuropathy in 8 (25.8%), acute motor and sensory axonal neuropathy in 3 (9.7%) and Miller Fisher syndrome in 2 (6.5%) patients. Twenty-one patients had received intravenous immunoglobulin, four had plasmapharesis, four had both while two patients received none of these. Ventilator support was required by seven patients. Tracheostomy was performed on two patients. The HSS was calculated at 3-month follow-up. Nineteen children (61.2%) had an HSS score of 0–1, eight had a score of 2–5 (25.8%), and four patients were lost to follow-up. Conclusion: HSS is a good tool to identify and follow children with GBS. More than two-thirds of the patients had recovered complete mobility at 3-month follow-up.
{"title":"Description of Guillain-Barre syndrome on the basis of clinical features using Hughes scoring system among children in Karachi, Pakistan","authors":"P. Chand, F. Jan, Sidra Kaleem, Mohammad Tahir Yousafzai, S. Ibrahim","doi":"10.4103/2542-3932.205193","DOIUrl":"https://doi.org/10.4103/2542-3932.205193","url":null,"abstract":"Background: Guillain-Barre syndrome (GBS) is an acquired inflammatory polyneuropathy characterized by rapidly progressive symmetrical flaccid limb weakness and areflexia. Here, we aimed to describe GBS on the basis of clinical features using Hughes scoring system (HSS) in children. Methods: We conducted a descriptive study, retrieving medical records of children between 2–16 years old admitted with GBS during January 2011–December 2013 at Aga Khan University Hospital, Karachi. Information on demographics, predisposing factors of GBS, clinical features at presentation, investigations, managements, short- and long-term outcomes were recorded on data extraction sheet. Ethical approval was obtained before data collection. Results: Totally 31 children with GBS (21 males) were admitted during the study period. The mean age was 6.7 years. Thirteen cases were seen in summer (January–October) followed by 11 in spring (March–May) and 7 in winter (November–February). Preceding illnesses including upper respiratory tract infections in 15 and diarrhea was seen in 4 patients. None of the patients had history of prior immunization. The nerve conduction study/electromyography showed acute inflammatory demyelinating polyradiculoneuropathy in 18 (58%), acute motor axonal neuropathy in 8 (25.8%), acute motor and sensory axonal neuropathy in 3 (9.7%) and Miller Fisher syndrome in 2 (6.5%) patients. Twenty-one patients had received intravenous immunoglobulin, four had plasmapharesis, four had both while two patients received none of these. Ventilator support was required by seven patients. Tracheostomy was performed on two patients. The HSS was calculated at 3-month follow-up. Nineteen children (61.2%) had an HSS score of 0–1, eight had a score of 2–5 (25.8%), and four patients were lost to follow-up. Conclusion: HSS is a good tool to identify and follow children with GBS. More than two-thirds of the patients had recovered complete mobility at 3-month follow-up.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74463830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: With the aging of the global population, an increasing number of people are at risk of developing Alzheimer's disease. There is currently no effective treatment to hinder or postpone the progression of Alzheimer's disease. Cholinesterase inhibitors and the N-methyl-D-aspartate receptor antagonist Memantine are the commonly prescribed drugs for this disease, but their therapeutic effects are still unsatisfactory. Therefore, there is an urgent need to investigate novel treatment methods. Many animal experiments have suggested that deep brain stimulation benefits Alzheimer's disease, but clinical trials investigating this are still in their infancy. This study aims to investigate the safety and effectiveness of deep brain stimulation in the treatment of severe Alzheimer's disease. Methods/Design: This study is a prospective, self-controlled, phase I trial (case observation), which will be performed in the Department of Neurosurgery, Chinese PLA General Hospital (Beijing, China). Six patients with severe Alzheimer's disease will be enrolled to receive continuous bilateral deep brain stimulation of the fornix. Evaluations will be performed at baseline (prior to surgery) and at 1, 6, and 12 months after surgery. The primary outcome measures are disability and mortality rates during the 12-month deep brain stimulation trial period. Secondary outcome measures include the incidence of complications and Clinical Dementia Rating scale, Zarit Caregiver Burden Interview, Mini-Mental State Examination, and Barthel Index of Activities of Daily Living Scale scores. Patient recruitment will begin in August 2017, the analysis of primary outcome measures will be completed in October 2018, and the study will finish in June 2019. Discussion: The results of this study will help to determine the safety of deep brain stimulation for the treatment of severe Alzheimer's disease. We will also assess whether deep brain stimulation can improve the cognition, symptoms, and activities of daily living of patients with Alzheimer's disease. If the study succeeds, a novel option for patients with Alzheimer's disease who respond poorly to current treatments may be provided. Trial registration: The study protocol is registered with ClinicalTrials.gov (identifier: NCT03115814). Ethics: The study protocol was approved by the Ethics Committee of Chinese PLA General Hospital (approval No. S2015-013-02) and will be performed in accordance with the Declaration of Helsinki formulated by the World Medical Association in 2013. Informed consent: Written informed consent will be obtained from each patient's legal representative.
背景:随着全球人口的老龄化，越来越多的人面临着患阿尔茨海默病的风险。目前还没有有效的治疗方法来阻止或延缓阿尔茨海默病的进展。胆碱酯酶抑制剂和n -甲基- d -天冬氨酸受体拮抗剂美金刚是治疗此病的常用药物，但其治疗效果仍不理想。因此，迫切需要探索新的治疗方法。许多动物实验表明，深部脑刺激对阿尔茨海默病有益，但对此进行的临床试验仍处于起步阶段。本研究旨在探讨脑深部电刺激治疗重度阿尔茨海默病的安全性和有效性。方法/设计:本研究为前瞻性、自我对照、一期临床试验(病例观察)，在中国人民解放军总医院(北京)神经外科进行。6名患有严重阿尔茨海默病的患者将接受双侧穹窿的持续深部脑刺激。评估将在基线(手术前)和手术后1、6和12个月进行。主要结局指标是12个月深部脑刺激试验期间的致残率和死亡率。次要结局指标包括并发症发生率、临床痴呆评定量表、Zarit照顾者负担访谈、迷你精神状态检查和Barthel日常生活活动指数评分。患者招募将于2017年8月开始，主要结局指标分析将于2018年10月完成，研究将于2019年6月结束。讨论:这项研究的结果将有助于确定深部脑刺激治疗严重阿尔茨海默病的安全性。我们还将评估脑深部刺激是否可以改善阿尔茨海默病患者的认知、症状和日常生活活动。如果这项研究取得成功，可能会为对当前治疗反应不佳的阿尔茨海默病患者提供一种新的选择。试验注册:研究方案已在ClinicalTrials.gov注册(标识符:NCT03115814)。伦理:本研究方案经中国人民解放军总医院伦理委员会批准(批准号:S2015-013-02)，并将按照2013年世界医学协会制定的《赫尔辛基宣言》进行。知情同意:从每位患者的法定代理人处获得书面知情同意。
{"title":"Deep brain stimulation for treatment of severe Alzheimer's disease: Study protocol for a prospective, self-controlled, phase I trial (case observation)","authors":"Zhiqi Mao, Xinguang Yu, Zhipei Ling, J. Jia, Longsheng Pan, Xin Xu, Zhi-qiang Cui, Ying Han, Shan-shan Wang, Shu-li Liang","doi":"10.4103/2542-3932.205196","DOIUrl":"https://doi.org/10.4103/2542-3932.205196","url":null,"abstract":"Background: With the aging of the global population, an increasing number of people are at risk of developing Alzheimer's disease. There is currently no effective treatment to hinder or postpone the progression of Alzheimer's disease. Cholinesterase inhibitors and the N-methyl-D-aspartate receptor antagonist Memantine are the commonly prescribed drugs for this disease, but their therapeutic effects are still unsatisfactory. Therefore, there is an urgent need to investigate novel treatment methods. Many animal experiments have suggested that deep brain stimulation benefits Alzheimer's disease, but clinical trials investigating this are still in their infancy. This study aims to investigate the safety and effectiveness of deep brain stimulation in the treatment of severe Alzheimer's disease. Methods/Design: This study is a prospective, self-controlled, phase I trial (case observation), which will be performed in the Department of Neurosurgery, Chinese PLA General Hospital (Beijing, China). Six patients with severe Alzheimer's disease will be enrolled to receive continuous bilateral deep brain stimulation of the fornix. Evaluations will be performed at baseline (prior to surgery) and at 1, 6, and 12 months after surgery. The primary outcome measures are disability and mortality rates during the 12-month deep brain stimulation trial period. Secondary outcome measures include the incidence of complications and Clinical Dementia Rating scale, Zarit Caregiver Burden Interview, Mini-Mental State Examination, and Barthel Index of Activities of Daily Living Scale scores. Patient recruitment will begin in August 2017, the analysis of primary outcome measures will be completed in October 2018, and the study will finish in June 2019. Discussion: The results of this study will help to determine the safety of deep brain stimulation for the treatment of severe Alzheimer's disease. We will also assess whether deep brain stimulation can improve the cognition, symptoms, and activities of daily living of patients with Alzheimer's disease. If the study succeeds, a novel option for patients with Alzheimer's disease who respond poorly to current treatments may be provided. Trial registration: The study protocol is registered with ClinicalTrials.gov (identifier: NCT03115814). Ethics: The study protocol was approved by the Ethics Committee of Chinese PLA General Hospital (approval No. S2015-013-02) and will be performed in accordance with the Declaration of Helsinki formulated by the World Medical Association in 2013. Informed consent: Written informed consent will be obtained from each patient's legal representative.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86849024","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-04-01DOI: 10.4103/2542-3932.205194
Qingwei Sun, J. Bao, Yuqian An, H. Lei, Jun Ma
Background: Apoptosis secondary to ischemia and hypoxia is the main cause of spinal cord dysfunction. Because of the decrease in atmospheric pressure, patients living on the Qinghai-Tibet Plateau are in a hypoxic environment, which is very unfavorable for the recovery of spinal cord injury. Hyperbaric oxygen therapy can improve the postoperative function of patients with incomplete spinal cord injury, and its effect is better on the plateau than at normal altitudes. We performed a prospective randomized controlled clinical trial to observe the effect of hyperbaric oxygen therapy on traumatic spinal cord injury in patients living on the Qinghai-Tibet Plateau and are currently analyzing the results. Methods/Design: This prospective, open-label, randomized controlled clinical trial was performed at the Department of Spine Surgery, Affiliated Hospital of Qinghai University, China. In total, 164 patients with incomplete traumatic spinal cord injury were equally and randomly assigned to a control group and a hyperbaric oxygen therapy group. Patients in the control group were treated with pedicle screw fixation and decompressive laminectomy. In addition to the surgical treatment performed in the control group, patients in the hyperbaric oxygen group underwent hyperbaric oxygen therapy at 0.2 MPa once a day for four treatment courses. Ten treatment sessions constituted one course, and each course was separated by a 5- to 7-day rest interval. The primary outcome was the modified Barthel index to assess activities of daily living. The secondary outcomes were the American Spinal Injury Association (ASIA) impairment scale grade, sensory score, and motor score. The partial results demonstrated that after four treatment courses (55–61 days), the modified Barthel index and ASIA tactile, pain, and motor scores were higher in the hyperbaric oxygen group than in the control group. The ASIA grades were significantly different between the hyperbaric oxygen group and control group. The proportion of patients with ASIA grades D and E was higher in the hyperbaric oxygen group than in the control group. Discussion: The study design was finished in May 2012. Patient recruitment began in June 2012 and finished until February 2016.Data analysis will be finished in December 2017. In this trial, we aim to determine the efficacy of hyperbaric oxygen therapy on the treatment of incomplete traumatic spinal cord injury in patients living on the plateau and to provide clinical evidence for treating incomplete traumatic spinal cord injury in these patients. Trial registration: ClinicalTrials.gov identifier: NCT03112941. Ethics: The study protocol has been approved by Ethics Committee, Affiliated Hospital of Qinghai University, China in April 2012 (approval number: QHC011K). Informed consent: Written informed consent was obtained from relatives or legal representatives.
{"title":"Hyperbaric oxygen therapy and comprehensive orthopedic treatment for incomplete traumatic spinal cord injury on the qinghai-tibet plateau: Study protocol for an open-label randomized controlled clinical trial","authors":"Qingwei Sun, J. Bao, Yuqian An, H. Lei, Jun Ma","doi":"10.4103/2542-3932.205194","DOIUrl":"https://doi.org/10.4103/2542-3932.205194","url":null,"abstract":"Background: Apoptosis secondary to ischemia and hypoxia is the main cause of spinal cord dysfunction. Because of the decrease in atmospheric pressure, patients living on the Qinghai-Tibet Plateau are in a hypoxic environment, which is very unfavorable for the recovery of spinal cord injury. Hyperbaric oxygen therapy can improve the postoperative function of patients with incomplete spinal cord injury, and its effect is better on the plateau than at normal altitudes. We performed a prospective randomized controlled clinical trial to observe the effect of hyperbaric oxygen therapy on traumatic spinal cord injury in patients living on the Qinghai-Tibet Plateau and are currently analyzing the results. Methods/Design: This prospective, open-label, randomized controlled clinical trial was performed at the Department of Spine Surgery, Affiliated Hospital of Qinghai University, China. In total, 164 patients with incomplete traumatic spinal cord injury were equally and randomly assigned to a control group and a hyperbaric oxygen therapy group. Patients in the control group were treated with pedicle screw fixation and decompressive laminectomy. In addition to the surgical treatment performed in the control group, patients in the hyperbaric oxygen group underwent hyperbaric oxygen therapy at 0.2 MPa once a day for four treatment courses. Ten treatment sessions constituted one course, and each course was separated by a 5- to 7-day rest interval. The primary outcome was the modified Barthel index to assess activities of daily living. The secondary outcomes were the American Spinal Injury Association (ASIA) impairment scale grade, sensory score, and motor score. The partial results demonstrated that after four treatment courses (55–61 days), the modified Barthel index and ASIA tactile, pain, and motor scores were higher in the hyperbaric oxygen group than in the control group. The ASIA grades were significantly different between the hyperbaric oxygen group and control group. The proportion of patients with ASIA grades D and E was higher in the hyperbaric oxygen group than in the control group. Discussion: The study design was finished in May 2012. Patient recruitment began in June 2012 and finished until February 2016.Data analysis will be finished in December 2017. In this trial, we aim to determine the efficacy of hyperbaric oxygen therapy on the treatment of incomplete traumatic spinal cord injury in patients living on the plateau and to provide clinical evidence for treating incomplete traumatic spinal cord injury in these patients. Trial registration: ClinicalTrials.gov identifier: NCT03112941. Ethics: The study protocol has been approved by Ethics Committee, Affiliated Hospital of Qinghai University, China in April 2012 (approval number: QHC011K). Informed consent: Written informed consent was obtained from relatives or legal representatives.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90655619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-04-01DOI: 10.4103/2542-3932.205195
F. Xue, J. Xiong, Peixun Zhang, Y. Kou, Shuai Han, Tian-bing Wang, Dian-ying Zhang, B. Jiang
Background: The optimal time to rescue spinal cord function after spinal cord injury is within 24 hours, especially within 3 to 8 hours, after the injury. Timely and proper pre-hospital first aid, hospital admission, patient assessment, and surgery are essential for the rescue of spinal cord function. A sound and rapid treatment system is the basis for improving the level of injury treatment and recovery of spinal cord function. China currently lacks a systematic and standardized treatment system. Methods/Design: We herein propose our study protocol for a prospective, multicenter, nonrandomized controlled trial. We will recruit 200 patients with acute spinal cord injury undergoing pre-hospital treatment at Beijing Emergency Medical Center and Beijing Red Cross Emergency Rescue Center and receiving in-hospital treatment at Peking University People's Hospital, Peking University Third Hospital, Beijing Friendship Hospital Affiliated to Capital Medical University, Chaoyang Hospital Affiliated to Capital Medical University, and Chinese PLA General Hospital, China. This study will comprise two parts: (1) establishment of a database of patients with spinal cord injury in the Beijing area; and (2) formulation of the pre-hospital and in-hospital process and establishment of a standardized treatment protocol for acute spinal cord injury. The primary outcome will be the American Spinal Injury Association impairment scale score for spinal nerve function. The secondary outcomes will be spinal X-ray, three-dimensional computed tomography, and magnetic resonance imaging findings and the incidence of complications due to improper pre-hospital and in-hospital treatment of acute spinal cord injury. Discussion: The aims of this study are as follows: (1) We will establish a spine and spinal cord injury treatment database in the Beijing area. (2) We will assess the complete pre-hospital and in-hospital evaluation of spine and spinal cord injury, develop and optimize first aid procedures, and create a pre-hospital and in-hospital standardized training program for the treatment of spine and spinal cord injury. (3) We will build a pre-hospital and in-hospital first aid “green channel” for acute spine and spinal cord injury after completion of the study. (4) We will develop first aid guidelines and establish an evaluation and treatment system for early surgery to save spinal cord function and reduce the degree of disability to the greatest extent as possible. (5) We anticipate that our results will be used in expert consensuses on acute spinal cord injury and that “green channel” patterns will be promoted in hospitals in Beijing and other cities of China to improve the level of first aid treatment of acute spine and spinal cord injury in Chinese cities and reduce the occurrence of secondary injury and severe dysfunction due to improper treatment. This trial will begin in May 2017. Patient recruitment will be finished in August 2019. Analysis of all data and results will
{"title":"Pre-hospital and in-hospital first aid programs and specifications for spine and spinal cord injury in Beijing, China: study protocol for a prospective, multicenter, nonrandomized controlled trial","authors":"F. Xue, J. Xiong, Peixun Zhang, Y. Kou, Shuai Han, Tian-bing Wang, Dian-ying Zhang, B. Jiang","doi":"10.4103/2542-3932.205195","DOIUrl":"https://doi.org/10.4103/2542-3932.205195","url":null,"abstract":"Background: The optimal time to rescue spinal cord function after spinal cord injury is within 24 hours, especially within 3 to 8 hours, after the injury. Timely and proper pre-hospital first aid, hospital admission, patient assessment, and surgery are essential for the rescue of spinal cord function. A sound and rapid treatment system is the basis for improving the level of injury treatment and recovery of spinal cord function. China currently lacks a systematic and standardized treatment system. Methods/Design: We herein propose our study protocol for a prospective, multicenter, nonrandomized controlled trial. We will recruit 200 patients with acute spinal cord injury undergoing pre-hospital treatment at Beijing Emergency Medical Center and Beijing Red Cross Emergency Rescue Center and receiving in-hospital treatment at Peking University People's Hospital, Peking University Third Hospital, Beijing Friendship Hospital Affiliated to Capital Medical University, Chaoyang Hospital Affiliated to Capital Medical University, and Chinese PLA General Hospital, China. This study will comprise two parts: (1) establishment of a database of patients with spinal cord injury in the Beijing area; and (2) formulation of the pre-hospital and in-hospital process and establishment of a standardized treatment protocol for acute spinal cord injury. The primary outcome will be the American Spinal Injury Association impairment scale score for spinal nerve function. The secondary outcomes will be spinal X-ray, three-dimensional computed tomography, and magnetic resonance imaging findings and the incidence of complications due to improper pre-hospital and in-hospital treatment of acute spinal cord injury. Discussion: The aims of this study are as follows: (1) We will establish a spine and spinal cord injury treatment database in the Beijing area. (2) We will assess the complete pre-hospital and in-hospital evaluation of spine and spinal cord injury, develop and optimize first aid procedures, and create a pre-hospital and in-hospital standardized training program for the treatment of spine and spinal cord injury. (3) We will build a pre-hospital and in-hospital first aid “green channel” for acute spine and spinal cord injury after completion of the study. (4) We will develop first aid guidelines and establish an evaluation and treatment system for early surgery to save spinal cord function and reduce the degree of disability to the greatest extent as possible. (5) We anticipate that our results will be used in expert consensuses on acute spinal cord injury and that “green channel” patterns will be promoted in hospitals in Beijing and other cities of China to improve the level of first aid treatment of acute spine and spinal cord injury in Chinese cities and reduce the occurrence of secondary injury and severe dysfunction due to improper treatment. This trial will begin in May 2017. Patient recruitment will be finished in August 2019. Analysis of all data and results will ","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85747643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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