SARS-Cov-19 virus is known to attack multiple organ systems including the brain and as a result, numerous of these patients manifest neurocognitive disorders. Moreover COVID-19, causes gastrointestinal symptoms such as nausea and vomiting, abdominal pain, diarrhea or constipation, loss of appetite and weight loss and these symptoms have been linked to neurocognitive dysfunction. According to studies, COVID-19 patients who report gastrointestinal symptoms as the predominant manifestations, perform worse on neurocognitive tests than those who do not suffer from such symptoms. In this study, we examined whether hospitalized COVID-19 patients with gastrointestinal symptoms presented neurocognitive dysfunction.
Materials and methods
The study enrolled 92 COVID-19 patients, hospitalized for 6–20 days, who were divided into 2 groups: the gastrointestinal group (GI) (n = 44) who presented with predominant gastrointestinal symptoms such as anorexia, nausea, vomiting, diarrhea and abdominal pain and the group without GI symptoms, (nGI) (n = 48), who reported fever, fatigue and symptoms from the respiratory system as the main symptoms. Neurocognitive assessment was performed by questionnaires administered to all patients, three months after the first positive PCR test for COVID-19.
Results
T-test was conducted for each test. Results revealed that patients with GI symptoms had significantly lower performance on neuropsychological functions such as complex scanning and long-term memory, visuospatial perception, executive function, verbal working memory and short-term memory, compared to patients without GI symptoms.
Conclusions
We found that there was a significant relationship between cognitive function and GI symptoms. This indicates that COVID-19 patients with GI symptoms may be at increased risk for developing deficits with their memory and other aspects of cognition.
{"title":"Do gastrointestinal symptoms influence neurocognitive functioning in COVID-19 patients?","authors":"Kalliopi Megari , Evanthia Thomaidou , Maria Theodoratou , Georgios Kougioumtzis , Soultana Papadopoulou , Dimitra V. Katsarou , Eleni Argiriadou","doi":"10.1016/j.jocn.2025.111147","DOIUrl":"10.1016/j.jocn.2025.111147","url":null,"abstract":"<div><h3>Background and objectives</h3><div>SARS-Cov-19 virus is known to attack multiple organ systems including the brain and as a result, numerous of these patients manifest neurocognitive disorders. Moreover COVID-19, causes gastrointestinal symptoms such as nausea and vomiting, abdominal pain, diarrhea or constipation, loss of appetite and weight loss and these symptoms have been linked to neurocognitive dysfunction. According to studies, COVID-19 patients who report gastrointestinal symptoms as the predominant manifestations, perform worse on neurocognitive tests than those who do not suffer from such symptoms. In this study, we examined whether hospitalized COVID-19 patients with gastrointestinal symptoms presented neurocognitive dysfunction.</div></div><div><h3>Materials and methods</h3><div>The study enrolled 92 COVID-19 patients, hospitalized for 6–20 days, who were divided into 2 groups: the gastrointestinal group (GI) (n = 44) who presented with predominant gastrointestinal symptoms such as anorexia, nausea, vomiting, diarrhea and abdominal pain and the group without GI symptoms, (nGI) (n = 48), who reported fever, fatigue and symptoms from the respiratory system as the main symptoms. Neurocognitive assessment was performed by questionnaires administered to all patients, three months after the first positive PCR test for COVID-19.</div></div><div><h3>Results</h3><div>T-test was conducted for each test. Results revealed that patients with GI symptoms had significantly lower performance on neuropsychological functions such as complex scanning and long-term memory, visuospatial perception, executive function, verbal working memory and short-term memory, compared to patients without GI symptoms.</div></div><div><h3>Conclusions</h3><div>We found that there was a significant relationship between cognitive function and GI symptoms. This indicates that COVID-19 patients with GI symptoms may be at increased risk for developing deficits with their memory and other aspects of cognition.</div></div>","PeriodicalId":15487,"journal":{"name":"Journal of Clinical Neuroscience","volume":"135 ","pages":"Article 111147"},"PeriodicalIF":1.9,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143508300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-27DOI: 10.1016/j.jocn.2025.111156
Mohamed G. Zeinhom , Mohamed Fouad elsayed Khalil , Tarek Youssif Omar Youssif , Ahmed Mohamed ali Daabis , Mohamed Almoataz , Hossam Mohamed Refat , Ahmed Ahmed Mohamed Kamal Ebied , Diaa Mostafa Atiaa Mohamed , Mohamed Ismaiel , Islam Fathallah Mohamed Kamel , Asmaa Ismail Ebrahim Elballat , Ahmed Zaki Omar Akl , Sherihan Rezk ahmed
Although topiramate and valproate are antiseizure medications that have many contraindications and could produce many side effects, they are still used as migraine preventive therapy in middle- and low-income countries. Several trials compared valproate versus topiramate in patients with migraine showed inconclusive results. We aimed to evaluate the tolerability and efficacy of valproate compared to topiramate in migraineurs from the Middle East and North Africa.
Our single-blinded, multi-centre, randomized controlled trial had two parallel groups: the (A) group, which included 300 patients who received valproate, and the (B) group, which included 300 patients who received topiramate.
In our trial, 574 patients completed the 3-month follow-up period. Topiramate achieved a greater reduction in migraine attack severity on VAS and HIT-6 than valproate to a degree that was statistically significant. 129 (43 %) patients in valproate group and 66 (22 %) in topiramate group had any adverse effects (HR 3.11; 95 % CI 1.08–6.13; P = 0.05), of which 23 patients (7.7 %) in valproate group and twelve patients (4 %) in the topiramate group stopped treatment prematurely due to intolerable adverse effects (HR 2.47; 95 % CI 1.04–5.88; P = 0.04).
We concluded that, in adult patients with migraine, the regular use of topiramate 50 mg Bid for three months yielded significantly higher reductions in migraine attack severity and HIT6 score compared to using valproate 500 mg Bid; valproate led to a significantly higher percentage of patients who prematurely stopped treatment due to intolerable adverse effects.
Trial registration: ClinicalTrials.gov, (NCT06248931)- 08 February 2024.
{"title":"Efficacy and tolerability of valproate versus topiramate in migraine prevention, a randomized controlled multi-center trial","authors":"Mohamed G. Zeinhom , Mohamed Fouad elsayed Khalil , Tarek Youssif Omar Youssif , Ahmed Mohamed ali Daabis , Mohamed Almoataz , Hossam Mohamed Refat , Ahmed Ahmed Mohamed Kamal Ebied , Diaa Mostafa Atiaa Mohamed , Mohamed Ismaiel , Islam Fathallah Mohamed Kamel , Asmaa Ismail Ebrahim Elballat , Ahmed Zaki Omar Akl , Sherihan Rezk ahmed","doi":"10.1016/j.jocn.2025.111156","DOIUrl":"10.1016/j.jocn.2025.111156","url":null,"abstract":"<div><div>Although topiramate and valproate are antiseizure medications that have many contraindications and could produce many side effects, they are still used as migraine preventive therapy in middle- and low-income countries. Several trials compared valproate versus topiramate in patients with migraine showed inconclusive results. We aimed to evaluate the tolerability and efficacy of valproate compared to topiramate in migraineurs from the Middle East and North Africa.</div><div>Our single-blinded, multi-centre, randomized controlled trial had two parallel groups: the (A) group, which included 300 patients who received valproate, and the (B) group, which included 300 patients who received topiramate.</div><div>In our trial, 574 patients completed the 3-month follow-up period. Topiramate achieved a greater reduction in migraine attack severity on VAS and HIT-6 than valproate to a degree that was statistically significant. 129 (43 %) patients in valproate group and 66 (22 %) in topiramate group had any adverse effects (HR 3.11; 95 % CI 1.08–6.13; P = 0.05), of which 23 patients (7.7 %) in valproate group and twelve patients (4 %) in the topiramate group stopped treatment prematurely due to intolerable adverse effects (HR 2.47; 95 % CI 1.04–5.88; P = 0.04).</div><div>We concluded that<strong>,</strong> in adult patients with migraine, the regular use of topiramate 50 mg Bid for three months yielded significantly higher reductions in migraine attack severity and HIT6 score compared to using valproate 500 mg Bid; valproate led to a significantly higher percentage of patients who prematurely stopped treatment due to intolerable adverse effects.</div><div>Trial registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, (NCT06248931)- 08 February 2024.</div></div>","PeriodicalId":15487,"journal":{"name":"Journal of Clinical Neuroscience","volume":"135 ","pages":"Article 111156"},"PeriodicalIF":1.9,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143511688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-27DOI: 10.1016/j.jocn.2025.111151
Shivani Sundaram , Xiecheng Shao , Ryan S. Chung , Roberto Martin del Campo Vera , Jonathon Cavaleri , Miguel Parra , Selena Zhang , Adith Swarup , Alexandra Kammen , Christi Heck , Charles Y. Liu , Spencer S. Kellis , Brian Lee
Introduction
The amygdala is mostly known for its roles in emotional processing and social behavior. In recent years, it has been implicated in voluntary motor control due to its structural and functional connectivity with the motor cortex. By investigating whether the amygdala modulates during movement preparation, we can further examine its contributions to motor processing.
Objective
We utilized a delayed reach task to measure beta-band (13–30 Hz) modulation in the amygdala during movement preparation. We hypothesized that we would see decreases in beta-band power during the Delay and Response phases of this task.
Methods
Eleven subjects diagnosed with drug-resistant epilepsy (DRE), who were implanted with stereoelectroencephalographic (SEEG) electrodes, were recruited to this study. The beta-band power was recorded through a delayed reach task. We calculated the beta-band Power Spectral Density (PSD) using multi-taper spectral analysis and compared the trial-averaged PSD using a cluster-based permutation test to determine the significance of beta-band power differences between task phases.
Results
100 % of participants and 44.8 % of gray matter contacts in the amygdala (n = 58) exhibited significantly decreased beta-band power during the Delay phase. During the Response phase, 90.9 % of participants and 58.6 % of gray matter contacts (n = 58) showed significantly decreased beta-band power. We also found a difference in the proportion of amygdala contacts showing beta-band modulation between those implanted in gray vs. white matter (p = 0.0035) but found no difference between contralateral vs. ipsilateral contacts (p = 0.17) and male vs. female participants (p = 0.34).
Conclusion
This study is the first to demonstrate beta-band power decreases in the amygdala during the Delay and Response phases of a delayed reach task. These findings demonstrate that the amygdala undergoes neural modulation prior to movement initiation and during movement execution.
{"title":"Beta-band power modulation in the human amygdala during a delayed reach task","authors":"Shivani Sundaram , Xiecheng Shao , Ryan S. Chung , Roberto Martin del Campo Vera , Jonathon Cavaleri , Miguel Parra , Selena Zhang , Adith Swarup , Alexandra Kammen , Christi Heck , Charles Y. Liu , Spencer S. Kellis , Brian Lee","doi":"10.1016/j.jocn.2025.111151","DOIUrl":"10.1016/j.jocn.2025.111151","url":null,"abstract":"<div><h3>Introduction</h3><div>The amygdala is mostly known for its roles in emotional processing and social behavior. In recent years, it has been implicated in voluntary motor control due to its structural and functional connectivity with the motor cortex. By investigating whether the amygdala modulates during movement preparation, we can further examine its contributions to motor processing.</div></div><div><h3>Objective</h3><div>We utilized a delayed reach task to measure beta-band (13–30 Hz) modulation in the amygdala during movement preparation. We hypothesized that we would see decreases in beta-band power during the Delay and Response phases of this task.</div></div><div><h3>Methods</h3><div>Eleven subjects diagnosed with drug-resistant epilepsy (DRE), who were implanted with stereoelectroencephalographic (SEEG) electrodes, were recruited to this study. The beta-band power was recorded through a delayed reach task. We calculated the beta-band Power Spectral Density (PSD) using multi-taper spectral analysis and compared the trial-averaged PSD using a cluster-based permutation test to determine the significance of beta-band power differences between task phases.</div></div><div><h3>Results</h3><div>100 % of participants and 44.8 % of gray matter contacts in the amygdala (n = 58) exhibited significantly decreased beta-band power during the Delay phase. During the Response phase, 90.9 % of participants and 58.6 % of gray matter contacts (n = 58) showed significantly decreased beta-band power. We also found a difference in the proportion of amygdala contacts showing beta-band modulation between those implanted in gray vs. white matter (p = 0.0035) but found no difference between contralateral vs. ipsilateral contacts (p = 0.17) and male vs. female participants (p = 0.34).</div></div><div><h3>Conclusion</h3><div>This study is the first to demonstrate beta-band power decreases in the amygdala during the Delay and Response phases of a delayed reach task. These findings demonstrate that the amygdala undergoes neural modulation prior to movement initiation and during movement execution.</div></div>","PeriodicalId":15487,"journal":{"name":"Journal of Clinical Neuroscience","volume":"135 ","pages":"Article 111151"},"PeriodicalIF":1.9,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143508396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy affecting the upper limb, with surgical intervention as the primary treatment. This study aims to identify predictive factors influencing postoperative motor and sensory recovery following carpal tunnel release (CTR).
Methods
A retrospective analysis was conducted on 95 patients (117 hands), with objective outcomes measured by tip pinch strength and two-point discrimination (2PD) six months postoperatively. Motor recovery was defined as the recovery rate of tip pinch strength ≥ 1.2, while sensory recovery was defined as 2PD < 6 mm. Predictive factors such as age, gender, body mass index, comorbidities, and preoperative physical strength were analyzed using univariate and multivariate logistic regression.
Results
Our study showed that younger patients (<73 years) and those patients with better preoperative sensory function had better significant postoperative sensory recovery (age: OR 5.5p = 0.003, 2PD: OR 3.3p = 0.042). Preoperative pinch strength was a significant predictor of motor recovery, while the presence of diabetes mellitus was associated with poorer sensory recovery. Although subjective measures such as the Quick DASH and visual analog scale improved postoperatively, they did not correlate with objective motor and sensory recovery.
Conclusions
These findings suggested the importance of preoperative differences in pinch strength, sensory function and age in predicting postoperative prognosis in patients with CTS. Understanding these prognostic factors may help clinicians to provide patients with different measures of subjective improvement and to manage their expectations.
{"title":"Prognostic indicators of postoperative objective improvement in carpal tunnel syndrome: A retrospective study","authors":"Shinsuke Morisaki , Kengo Yoshii , Shinji Tsuchida , Ryo Oda , Kenji Takahashi","doi":"10.1016/j.jocn.2025.111145","DOIUrl":"10.1016/j.jocn.2025.111145","url":null,"abstract":"<div><h3>Background</h3><div>Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy affecting the upper limb, with surgical intervention as the primary treatment. This study aims to identify predictive factors influencing postoperative motor and sensory recovery following carpal tunnel release (CTR).</div></div><div><h3>Methods</h3><div>A retrospective analysis was conducted on 95 patients (117 hands), with objective outcomes measured by tip pinch strength and two-point discrimination (2PD) six months postoperatively. Motor recovery was defined as the recovery rate of tip pinch strength ≥ 1.2, while sensory recovery was defined as 2PD < 6 mm. Predictive factors such as age, gender, body mass index, comorbidities, and preoperative physical strength were analyzed using univariate and multivariate logistic regression.</div></div><div><h3>Results</h3><div>Our study showed that younger patients (<73 years) and those patients with better preoperative sensory function had better significant postoperative sensory recovery (age: OR 5.5p = 0.003, 2PD: OR 3.3p = 0.042). Preoperative pinch strength was a significant predictor of motor recovery, while the presence of diabetes mellitus was associated with poorer sensory recovery. Although subjective measures such as the Quick DASH and visual analog scale improved postoperatively, they did not correlate with objective motor and sensory recovery.</div></div><div><h3>Conclusions</h3><div>These findings suggested the importance of preoperative differences in pinch strength, sensory function and age in predicting postoperative prognosis in patients with CTS. Understanding these prognostic factors may help clinicians to provide patients with different measures of subjective improvement and to manage their expectations.</div></div>","PeriodicalId":15487,"journal":{"name":"Journal of Clinical Neuroscience","volume":"135 ","pages":"Article 111145"},"PeriodicalIF":1.9,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143508395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-26DOI: 10.1016/j.jocn.2025.111150
Trent Kite , Vineetha Yadlapalli , John Herbst , Stephen Karlovits , Rodney E. Wegner , Matthew J. Shepard
Introduction
High-grade gliomas (WHO Grade III and IV) invariably recur. Standardized management in the recurrent setting is ill defined. Stereotactic radiosurgery (SRS) represents a non-invasive treatment modality. Evidence to date is limited and therefore further evaluation of the role of SRS in recurrent high-grade-gliomas (rHGG) is warranted.
Methods
We conducted a retrospective cohort study consisting of 33 patients with rHGGs treated with SRS from January 2020 to June 2024. Baseline demographics, radiosurgical parameters, and outcomes/toxicity data were collected. Descriptive statistics were calculated for all continuous variables. Survival analysis was performed using the Kaplan Meier method. Univariate analysis was performed using Cox proportional hazard model. All statistics were performed in GraphPad Prism (V.10).
Results
Thirty-three patients with 44 rHGG lesions underwent Gamma Knife SRS with a median of 5 fractions (range:1–5). Overall local control at 3-,6-, and 12-months was 69.9 %, 45.9 %, and 31.9 % respectively. Distant tumor control at 3-,6-, and 12-months was 71.7 %, 48.2 %, and 42.2 %. Global tumor control was at 3-,6, and 12-months was 69.9 %, 45.9 %, 31.9 % respectively. Median OS from the time of SRS was 7 months (95 % CI: 6.65–17.23). Median PFS from the time of SRS was 5.5 months (95 % CI: 4.79–14.31). MGMT methylated status was associated with improved OS (HR: 0.24 95 % CI: 0.07–0.60, P = 0.01).
Conclusions
SRS affords reasonable local control in the short term for patients with recurrent HGG who are otherwise poor surgical candidates. Local failure is more common than distant failure, albeit global control is critical in increasing PFS. MGMT methylated status is associated with increased overall survival.
{"title":"Stereotactic radiosurgery for recurrent high-grade gliomas","authors":"Trent Kite , Vineetha Yadlapalli , John Herbst , Stephen Karlovits , Rodney E. Wegner , Matthew J. Shepard","doi":"10.1016/j.jocn.2025.111150","DOIUrl":"10.1016/j.jocn.2025.111150","url":null,"abstract":"<div><h3>Introduction</h3><div>High-grade gliomas (WHO Grade III and IV) invariably recur. Standardized management in the recurrent setting is ill defined. Stereotactic radiosurgery (SRS) represents a non-invasive treatment modality. Evidence to date is limited and therefore further evaluation of the role of SRS in recurrent high-grade-gliomas (rHGG) is warranted.</div></div><div><h3>Methods</h3><div>We conducted a retrospective cohort study consisting of 33 patients with rHGGs treated with SRS from January 2020 to June 2024. Baseline demographics, radiosurgical parameters, and outcomes/toxicity data were collected. Descriptive statistics were calculated for all continuous variables. Survival analysis was performed using the Kaplan Meier method. Univariate analysis was performed using Cox proportional hazard model. All statistics were performed in GraphPad Prism (V.10).</div></div><div><h3>Results</h3><div>Thirty-three patients with 44 rHGG lesions underwent Gamma Knife SRS with a median of 5 fractions (range:1–5). Overall local control at 3-,6-, and 12-months was 69.9 %, 45.9 %, and 31.9 % respectively. Distant tumor control at 3-,6-, and 12-months was 71.7 %, 48.2 %, and 42.2 %. Global tumor control was at 3-,6, and 12-months was 69.9 %, 45.9 %, 31.9 % respectively. Median OS from the time of SRS was 7 months (95 % CI: 6.65–17.23). Median PFS from the time of SRS was 5.5 months (95 % CI: 4.79–14.31). MGMT methylated status was associated with improved OS (HR: 0.24 95 % CI: 0.07–0.60, P = 0.01).</div></div><div><h3>Conclusions</h3><div>SRS affords reasonable local control in the short term for patients with recurrent HGG who are otherwise poor surgical candidates. Local failure is more common than distant failure, albeit global control is critical in increasing PFS. MGMT methylated status is associated with increased overall survival.</div></div>","PeriodicalId":15487,"journal":{"name":"Journal of Clinical Neuroscience","volume":"135 ","pages":"Article 111150"},"PeriodicalIF":1.9,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143488178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-26DOI: 10.1016/j.jocn.2025.111148
Nicholas Kendall , Zach Pennington , Abdelrahman M Hamouda , Mark Cwajna , Sherief Ghozy , David F Kallmes , Benjamin D Elder
Introduction
ClinicalTrials.gov is an online database that was launched in 2000 in order to help increase transparency around clinical trials. The FDA’s Food and Drug Administration Amendments Act of 2007 and the subsequent Final Rule of 2016 attempted to improve compliance for reporting to the site. However, there is still significant noncompliance by researchers. This study evaluated compliance for trials related to spinal stenosis and spinal fusion.
Methods
We utilized a previously published algorithm to predict clinical trials that were highly likely to be mandated to report. Trials found under the search criteria “Spinal Fusion OR Spinal Stenosis” and completed before June 2023 were extracted. Data was extracted from ClinicalTrials.gov on Study Status, Study Results, Interventions, Phases, Funder Type, Study Type, Study Design, Start Date, Primary Completion Date, Results First Posted and Study Locations. Additionally, the number of months between the primary completion date and the reporting of the results in the database were calculated for each study. Due to limited data points, descriptive analysis was conducted.
Results
We found 86 studies that were deemed highly likely to be mandated to report. Of these trials, 13 % reported results within 12 months, and 85 % reported within 5 years. Industry (44 %) and other non-federal sources (54 %) were the primary funders, with the NIH funding none of the included studies. Median reporting times were similar across funding sources. Upon analysis, there were no factors that were significantly related to reporting in the 1-year time frame. The only significant factor for 5-year reporting was the year of study completion, with studies completed in 2016 or later showing 100 % compliance.
Conclusion
This study highlights improvements in reporting within 5 years since the 2016 Final Rule. However, despite regulatory efforts, there remains an increased need for reporting compliance in spinal fusion and spinal stenosis clinical trials. Continued efforts are needed to ensure increased transparency.
{"title":"Compliance and factors affecting reporting of spinal stenosis and spinal-fusion-related clinical trials to ClinicalTrials.gov","authors":"Nicholas Kendall , Zach Pennington , Abdelrahman M Hamouda , Mark Cwajna , Sherief Ghozy , David F Kallmes , Benjamin D Elder","doi":"10.1016/j.jocn.2025.111148","DOIUrl":"10.1016/j.jocn.2025.111148","url":null,"abstract":"<div><h3>Introduction</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> is an online database that was launched in 2000 in order to help increase transparency around clinical trials. The FDA’s Food and Drug Administration Amendments Act of 2007 and the subsequent Final Rule of 2016 attempted to improve compliance for reporting to the site. However, there is still significant noncompliance by researchers. This study evaluated compliance for trials related to spinal stenosis and spinal fusion.</div></div><div><h3>Methods</h3><div>We utilized a previously published algorithm to predict clinical trials that were highly likely to be mandated to report. Trials found under the search criteria “Spinal Fusion OR Spinal Stenosis” and completed before June 2023 were extracted. Data was extracted from <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> on Study Status, Study Results, Interventions, Phases, Funder Type, Study Type, Study Design, Start Date, Primary Completion Date, Results First Posted and Study Locations. Additionally, the number of months between the primary completion date and the reporting of the results in the database were calculated for each study. Due to limited data points, descriptive analysis was conducted.</div></div><div><h3>Results</h3><div>We found 86 studies that were deemed highly likely to be mandated to report. Of these trials, 13 % reported results within 12 months, and 85 % reported within 5 years. Industry (44 %) and other non-federal sources (54 %) were the primary funders, with the NIH funding none of the included studies. Median reporting times were similar across funding sources. Upon analysis, there were no factors that were significantly related to reporting in the 1-year time frame. The only significant factor for 5-year reporting was the year of study completion, with studies completed in 2016 or later showing 100 % compliance.</div></div><div><h3>Conclusion</h3><div>This study highlights improvements in reporting within 5 years since the 2016 Final Rule. However, despite regulatory efforts, there remains an increased need for reporting compliance in spinal fusion and spinal stenosis clinical trials. Continued efforts are needed to ensure increased transparency.</div></div>","PeriodicalId":15487,"journal":{"name":"Journal of Clinical Neuroscience","volume":"135 ","pages":"Article 111148"},"PeriodicalIF":1.9,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143488179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-26DOI: 10.1016/j.jocn.2025.111146
Naghmeh Abbasi Kasbi , Shima Jahani , Sajjad Ghane Ezabadi , Kosar Kohandel , Faezeh Khodaie , Amir Hossein Sahraian , Melika Arab-barfarni , Amir Almasi-Hashiani , Sharareh Eskandarieh , Mohammad Ali Sahraian
<div><h3>Introduction</h3><div>Late-onset multiple sclerosis (LOMS) was increasingly reported over the past two decades. Understanding the risk factors associated with LOMS can help improve early diagnosis, prevention strategies, and patients’ quality of life. This study aimed to assess various environmental risk factors in the patients with late-onset disease.</div></div><div><h3>Methods</h3><div>This study utilized a population-based case-control study design. Primary data on verified LOMS cases were received from Iran’s national MS registry, with additional information gained via telephone interviews. The potential risk factors for LOMS were examined using a questionnaire modified from global case-control studies. Age and sex-matched healthy controls were selected using face-to-face interviews. The collected data were analyzed using matched logistic regression in Stata software version 14, reporting adjusted odds ratios (OR), and 95 % confidence intervals, with a significance level set at p < 0.05.</div></div><div><h3>Results</h3><div>This study examined 82 LOMS cases and 207 matched controls. The mean age of cases and controls was 61 years. The findings revealed that moderate and high sunlight exposure during adolescence were related with 0.33 (95 % CI: 0.18–0.58) and 0.15 (95 % CI: 0.04–0.46) times decreased risks of developing LOMS, respectively. Similarly, compared to those with low sunlight exposure, participants with high and moderate sunlight exposure during adulthood had a lower chance of developing MS disease (OR = 0.35, 95 % CI: 0.18–0.69) and (OR = 0.40 95 % CI: 0.18–0.85) receptively. Moreover, age at first menstruation (p = 0.45), age at first delivery (p = 0.49), abortion history (p = 0.79), and oral contraceptive consumption (p = 0.18) did not significantly differ among the groups (all p > 0.05). The odds of developing LOMS were 2.47 (95 % CI: 1.05–5.81) times higher for 10 to 90 min of heavy physical activity per week and 2.39 (95 % CI: 1.08–5.27) times higher for over 90 min. Various emotional stress, including death of a loved one (OR = 2.19, 95 % CI: 1.07–4.48), family disruption (OR = 2.93 95 % CI: 1.62–1.02), homelessness (OR = 9.1 95 % CI: 1.4–57.5), employment dismissal (OR = 4.0, 95 % CI: 1.31–12.1), and unemployment (OR = 3.1, 95 % CI: 1.25–7.62), were significantly associated with an increased risk of developing LOMS. Depression (OR = 5.5, 95 % CI: 2.7–10.9), measles (OR = 2.63, 95 % CI: 1.4–4.8), and a family history of MS (OR = 4.7, 95 % CI: 1.4–15.6) were also associated with higher risk of LOMS development.</div></div><div><h3>Conclusion</h3><div>Sunlight exposure was shown to have a strong protective impact against LOMS. Furthermore, intensive physical activity, psychological stresses such as family upheavals, medical illnesses such as depression, and a positive family history of MS may all be associated with an increased risk of LOMS. These findings emphasized the importance of preventive measures for olde
{"title":"Environmental risk factors of late-onset multiple sclerosis: A population-based case-control study","authors":"Naghmeh Abbasi Kasbi , Shima Jahani , Sajjad Ghane Ezabadi , Kosar Kohandel , Faezeh Khodaie , Amir Hossein Sahraian , Melika Arab-barfarni , Amir Almasi-Hashiani , Sharareh Eskandarieh , Mohammad Ali Sahraian","doi":"10.1016/j.jocn.2025.111146","DOIUrl":"10.1016/j.jocn.2025.111146","url":null,"abstract":"<div><h3>Introduction</h3><div>Late-onset multiple sclerosis (LOMS) was increasingly reported over the past two decades. Understanding the risk factors associated with LOMS can help improve early diagnosis, prevention strategies, and patients’ quality of life. This study aimed to assess various environmental risk factors in the patients with late-onset disease.</div></div><div><h3>Methods</h3><div>This study utilized a population-based case-control study design. Primary data on verified LOMS cases were received from Iran’s national MS registry, with additional information gained via telephone interviews. The potential risk factors for LOMS were examined using a questionnaire modified from global case-control studies. Age and sex-matched healthy controls were selected using face-to-face interviews. The collected data were analyzed using matched logistic regression in Stata software version 14, reporting adjusted odds ratios (OR), and 95 % confidence intervals, with a significance level set at p < 0.05.</div></div><div><h3>Results</h3><div>This study examined 82 LOMS cases and 207 matched controls. The mean age of cases and controls was 61 years. The findings revealed that moderate and high sunlight exposure during adolescence were related with 0.33 (95 % CI: 0.18–0.58) and 0.15 (95 % CI: 0.04–0.46) times decreased risks of developing LOMS, respectively. Similarly, compared to those with low sunlight exposure, participants with high and moderate sunlight exposure during adulthood had a lower chance of developing MS disease (OR = 0.35, 95 % CI: 0.18–0.69) and (OR = 0.40 95 % CI: 0.18–0.85) receptively. Moreover, age at first menstruation (p = 0.45), age at first delivery (p = 0.49), abortion history (p = 0.79), and oral contraceptive consumption (p = 0.18) did not significantly differ among the groups (all p > 0.05). The odds of developing LOMS were 2.47 (95 % CI: 1.05–5.81) times higher for 10 to 90 min of heavy physical activity per week and 2.39 (95 % CI: 1.08–5.27) times higher for over 90 min. Various emotional stress, including death of a loved one (OR = 2.19, 95 % CI: 1.07–4.48), family disruption (OR = 2.93 95 % CI: 1.62–1.02), homelessness (OR = 9.1 95 % CI: 1.4–57.5), employment dismissal (OR = 4.0, 95 % CI: 1.31–12.1), and unemployment (OR = 3.1, 95 % CI: 1.25–7.62), were significantly associated with an increased risk of developing LOMS. Depression (OR = 5.5, 95 % CI: 2.7–10.9), measles (OR = 2.63, 95 % CI: 1.4–4.8), and a family history of MS (OR = 4.7, 95 % CI: 1.4–15.6) were also associated with higher risk of LOMS development.</div></div><div><h3>Conclusion</h3><div>Sunlight exposure was shown to have a strong protective impact against LOMS. Furthermore, intensive physical activity, psychological stresses such as family upheavals, medical illnesses such as depression, and a positive family history of MS may all be associated with an increased risk of LOMS. These findings emphasized the importance of preventive measures for olde","PeriodicalId":15487,"journal":{"name":"Journal of Clinical Neuroscience","volume":"135 ","pages":"Article 111146"},"PeriodicalIF":1.9,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143488177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Diffusion tensor imaging (DTI) can be used to detect early signs of increased water diffusivity in white matter tracts in patients with mild cognitive impairment (MCI). This study examined how DTI, alongside cerebrospinal fluid (CSF) biomarkers (like tau proteins and amyloid-β), can help identify early brain changes in MCI. We included 159 individuals (92 with MCI and 67 healthy controls) from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) and extracted their demographics, CSF biomarkers, and DTI metrics. We compared the biomarkers (CSF biomarkers and DTI markers in 57 white matter tracts) between the two study groups using a general linear model, adjusting for age, sex, and handedness. CSF biomarker levels showed a statistically significant difference between the two study groups. Also, diffusion properties of left Cingulum and left Uncinate fasciculus in both groups were statistically different. Additionally, we explored possible associations between CSF and DTI markers in the MCI group. Our results indicated several statistically significant associations between DTI metrics and CSF biomarkers within specific white matter tracts. These findings underscore the complexity of imaging and molecular markers associated with MCI.
{"title":"Associations between diffusion tensor imaging patterns and cerebrospinal fluid markers in mild cognitive impairment","authors":"Nafise Niknam , Sara Khaefi , Hadise Heidarpour , Mohammad Sadeghi , Narges Azari Jafari , Sheida Mohammadi , Zeinab Ahmadi , Ramin Ahangar-Sirous , Mahsa Mayeli , Homa Seyedmirzaei , Alzheimer’s Disease Neuroimaging Initiative","doi":"10.1016/j.jocn.2025.111141","DOIUrl":"10.1016/j.jocn.2025.111141","url":null,"abstract":"<div><div>Diffusion tensor imaging (DTI) can be used to detect early signs of increased water diffusivity in white matter tracts in patients with mild cognitive impairment (MCI). This study examined how DTI, alongside cerebrospinal fluid (CSF) biomarkers (like tau proteins and amyloid-β), can help identify early brain changes in MCI. We included 159 individuals (92 with MCI and 67 healthy controls) from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) and extracted their demographics, CSF biomarkers, and DTI metrics. We compared the biomarkers (CSF biomarkers and DTI markers in 57 white matter tracts) between the two study groups using a general linear model, adjusting for age, sex, and handedness. CSF biomarker levels showed a statistically significant difference between the two study groups. Also, diffusion properties of left Cingulum and left Uncinate fasciculus in both groups were statistically different. Additionally, we explored possible associations between CSF and DTI markers in the MCI group. Our results indicated several statistically significant associations between DTI metrics and CSF biomarkers within specific white matter tracts. These findings underscore the complexity of imaging and molecular markers associated with MCI.</div></div>","PeriodicalId":15487,"journal":{"name":"Journal of Clinical Neuroscience","volume":"135 ","pages":"Article 111141"},"PeriodicalIF":1.9,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143488244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-25DOI: 10.1016/j.jocn.2025.111152
Mehmet Yigit Akgun , Melihcan Savasci , Caner Gunerbuyuk , Sezer Onur Gunara , Tunc Oktenoglu , Ali Fahir Ozer , Ozkan Ates
Background
The advancement of artificial intelligence (AI) has led to its application in various fields, including medical literature. This study compares the quality of neurosurgery articles written by human authors and those generated by ChatGPT, an advanced AI model. The objective was to determine if AI-generated articles meet the standards of human-written academic papers.
Methods
A total of 10 neurosurgery articles, 5 written by humans and 5 by ChatGPT, were evaluated by a panel of blinded experts. The assessment parameters included overall impression, readability, criteria satisfaction, and degree of detail. Additionally, readability scores were calculated using the Lix score and the Flesch-Kincaid grade level. Preference and identification tests were also conducted to determine if experts could distinguish between the two types of articles.
Results
The study found no significant differences in the overall quality parameters between human-written and ChatGPT −generated articles. Readability scores were higher for ChatGPT articles (Lix score: 35 vs. 26, Flesch-Kincaid grade level: 10 vs. 8). Experts correctly identified the authorship of the articles 61% of the time, with preferences almost evenly split (47% preferred CHATGPT, 44% preferred human, and 9% had no preference). The most statistically significant result was the higher readability scores of CHATGPT-generated articles, indicating that AI can produce more readable content than human authors.
Conclusion
ChatGPT is capable of generating neurosurgery articles that are comparable in quality to those written by humans. The higher readability scores of AI-generated articles suggest that ChatGPT can enhance the accessibility of scientific literature. This study supports the potential integration of AI in academic writing, offering a valuable tool for researchers and medical professionals.
{"title":"Battle of the authors: Comparing neurosurgery articles written by humans and AI","authors":"Mehmet Yigit Akgun , Melihcan Savasci , Caner Gunerbuyuk , Sezer Onur Gunara , Tunc Oktenoglu , Ali Fahir Ozer , Ozkan Ates","doi":"10.1016/j.jocn.2025.111152","DOIUrl":"10.1016/j.jocn.2025.111152","url":null,"abstract":"<div><h3>Background</h3><div>The advancement of artificial intelligence (AI) has led to its application in various fields, including medical literature. This study compares the quality of neurosurgery articles written by human authors and those generated by ChatGPT, an advanced AI model. The objective was to determine if AI-generated articles meet the standards of human-written academic papers.</div></div><div><h3>Methods</h3><div>A total of 10 neurosurgery articles, 5 written by humans and 5 by ChatGPT, were evaluated by a panel of blinded experts. The assessment parameters included overall impression, readability, criteria satisfaction, and degree of detail. Additionally, readability scores were calculated using the Lix score and the Flesch-Kincaid grade level. Preference and identification tests were also conducted to determine if experts could distinguish between the two types of articles.</div></div><div><h3>Results</h3><div>The study found no significant differences in the overall quality parameters between human-written and ChatGPT −generated articles. Readability scores were higher for ChatGPT articles (Lix score: 35 vs. 26, Flesch-Kincaid grade level: 10 vs. 8). Experts correctly identified the authorship of the articles 61% of the time, with preferences almost evenly split (47% preferred CHATGPT, 44% preferred human, and 9% had no preference). The most statistically significant result was the higher readability scores of CHATGPT-generated articles, indicating that AI can produce more readable content than human authors.</div></div><div><h3>Conclusion</h3><div>ChatGPT is capable of generating neurosurgery articles that are comparable in quality to those written by humans. The higher readability scores of AI-generated articles suggest that ChatGPT can enhance the accessibility of scientific literature. This study supports the potential integration of AI in academic writing, offering a valuable tool for researchers and medical professionals.</div></div>","PeriodicalId":15487,"journal":{"name":"Journal of Clinical Neuroscience","volume":"135 ","pages":"Article 111152"},"PeriodicalIF":1.9,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143488126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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