Background: The purpose of the study was to explore social anxiety in adolescents as well as associated factors, such as parenting styles, self-esteem, quality of life, emotional intelligence, and brain activity, in social anxiety.
Methods: A systematic review of articles related to social anxiety in adolescents, associated factors, and brain activity from 2012 to 2022 was performed. Google Scholar, PubMed, and Science Direct were used as research gates to find the relevant articles.
Results: Ten articles were sorted among 50 articles according to inclusion criteria. The included studies were based in Pakistan, India, and China, which indicated similar results. Social anxiety was directly related to low self-esteem, authoritarian parenting style, interbrain synchrony between parents and adolescents, low quality of life, weak emotional intelligence, and higher activity in the amygdala of the brain.
Conclusion: Social anxiety is common in male-dominant (patriarchal) societies where authoritarian parenting is practiced, which leads to low self-esteem, weak emotional intelligence, and low quality of life in adolescents. Social anxiety is also associated with higher activity in the amygdala and lower gamma interbrain synchrony.
{"title":"Role of Parenting and Psychosocial Correlates Contributing to Social Anxiety in Asian Adolescents: A Systematic Review.","authors":"Uzma Ilyas, Saima Dawood Khan","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>The purpose of the study was to explore social anxiety in adolescents as well as associated factors, such as parenting styles, self-esteem, quality of life, emotional intelligence, and brain activity, in social anxiety.</p><p><strong>Methods: </strong>A systematic review of articles related to social anxiety in adolescents, associated factors, and brain activity from 2012 to 2022 was performed. Google Scholar, PubMed, and Science Direct were used as research gates to find the relevant articles.</p><p><strong>Results: </strong>Ten articles were sorted among 50 articles according to inclusion criteria. The included studies were based in Pakistan, India, and China, which indicated similar results. Social anxiety was directly related to low self-esteem, authoritarian parenting style, interbrain synchrony between parents and adolescents, low quality of life, weak emotional intelligence, and higher activity in the amygdala of the brain.</p><p><strong>Conclusion: </strong>Social anxiety is common in male-dominant (patriarchal) societies where authoritarian parenting is practiced, which leads to low self-esteem, weak emotional intelligence, and low quality of life in adolescents. Social anxiety is also associated with higher activity in the amygdala and lower gamma interbrain synchrony.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 7-9","pages":"30-36"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10561979/pdf/icns_20_7-9_30.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41199766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Osteopathic manipulative treatment (OMT) is a hands-on therapy that aims to promote homeostasis by individuating and treating somatic dysfunctions (SDs), including alterations in muscular tissue. Presently, patients affected by neurological disorders (e.g., Parkinson's disease [PD], multiple sclerosis [MS], and mild traumatic brain injury) often present to the osteopaths for treatment of motor symptoms, fatigue, stiffness, and chronic pain. OMT could be a safe adjunct treatment to promote physical wellness in such patients. However, there are many unanswered questions about its efficacy, especially regarding patients with neurological diseases. In this commentary, the authors encourage and promote the implementation of OMT as a complementary therapy in the neurorehabilitation field.
{"title":"Back to the Future: An Appraisal of the Role of Osteopathic Manipulative Treatment in Patients with Neurological Diseases.","authors":"Mirjam Bonanno, Rocco Salvatore Calabrò","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Osteopathic manipulative treatment (OMT) is a hands-on therapy that aims to promote homeostasis by individuating and treating somatic dysfunctions (SDs), including alterations in muscular tissue. Presently, patients affected by neurological disorders (e.g., Parkinson's disease [PD], multiple sclerosis [MS], and mild traumatic brain injury) often present to the osteopaths for treatment of motor symptoms, fatigue, stiffness, and chronic pain. OMT could be a safe adjunct treatment to promote physical wellness in such patients. However, there are many unanswered questions about its efficacy, especially regarding patients with neurological diseases. In this commentary, the authors encourage and promote the implementation of OMT as a complementary therapy in the neurorehabilitation field.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 7-9","pages":"8-10"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10561987/pdf/icns_20_7-9_8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41199748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jacqueline Lutz, Abhishek Pratap, Eric J Lenze, Durga Bestha, Jessica M Lipschitz, Stella Karantzoulis, Uma Vaidyanathan, Jessica Robin, William Horan, Stephen Brannan, Aurelia Mittoux, Michael C Davis, Shaheen E Lakhan, Richard Keefe
Objective: Recruitment of a sufficiently large and representative patient sample and its retention during central nervous system (CNS) trials presents major challenges for study sponsors. Technological advances are reshaping clinical trial operations to meet these challenges, and the COVID-19 pandemic further accelerated this development.
Method of research: The International Society for CNS Clinical Trials and Methodology (ISCTM; www.isctm.org) Innovative Technologies for CNS Trials Working Group surveyed the state of technological innovations for improved recruitment and retention and assessed their promises and pitfalls.
Results: Online advertisement and electronic patient registries can enhance recruitment, but challenges with sample representativeness, conversion rates from eligible prescreening to enrolled patients, data privacy and security, and patient identification remain hurdles for optimal use of these technologies. Electronic medical records (EMR) mining with artificial intelligence (AI)/machine learning (ML) methods is promising but awaits translation into trials. During the study treatment phase, technological innovations increasingly support participant retention, including adherence with the investigational treatment. Digital tools for adherence and retention support take many forms, including patient-centric communication channels between researchers and participants, real-time study reminders, and digital behavioral interventions to increase study compliance. However, such tools add technical complexities to trials, and their impact on the generalizability of results are largely unknown.
Conclusion: Overall, the group found a scarcity of systematic data directly assessing the impact of technological innovations on study recruitment and retention in CNS trials, even for strategies with already high adoption, such as online recruitment. Given the added complexity and costs associated with most technological innovations, such data is needed to fully harness technologies for CNS trials and drive further adoption.
{"title":"Innovative Technologies in CNS Trials: Promises and Pitfalls for Recruitment, Retention, and Representativeness.","authors":"Jacqueline Lutz, Abhishek Pratap, Eric J Lenze, Durga Bestha, Jessica M Lipschitz, Stella Karantzoulis, Uma Vaidyanathan, Jessica Robin, William Horan, Stephen Brannan, Aurelia Mittoux, Michael C Davis, Shaheen E Lakhan, Richard Keefe","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>Recruitment of a sufficiently large and representative patient sample and its retention during central nervous system (CNS) trials presents major challenges for study sponsors. Technological advances are reshaping clinical trial operations to meet these challenges, and the COVID-19 pandemic further accelerated this development.</p><p><strong>Method of research: </strong>The International Society for CNS Clinical Trials and Methodology (ISCTM; www.isctm.org) Innovative Technologies for CNS Trials Working Group surveyed the state of technological innovations for improved recruitment and retention and assessed their promises and pitfalls.</p><p><strong>Results: </strong>Online advertisement and electronic patient registries can enhance recruitment, but challenges with sample representativeness, conversion rates from eligible prescreening to enrolled patients, data privacy and security, and patient identification remain hurdles for optimal use of these technologies. Electronic medical records (EMR) mining with artificial intelligence (AI)/machine learning (ML) methods is promising but awaits translation into trials. During the study treatment phase, technological innovations increasingly support participant retention, including adherence with the investigational treatment. Digital tools for adherence and retention support take many forms, including patient-centric communication channels between researchers and participants, real-time study reminders, and digital behavioral interventions to increase study compliance. However, such tools add technical complexities to trials, and their impact on the generalizability of results are largely unknown.</p><p><strong>Conclusion: </strong>Overall, the group found a scarcity of systematic data directly assessing the impact of technological innovations on study recruitment and retention in CNS trials, even for strategies with already high adoption, such as online recruitment. Given the added complexity and costs associated with most technological innovations, such data is needed to fully harness technologies for CNS trials and drive further adoption.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 7-9","pages":"40-46"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10561984/pdf/icns_20_7-9_40.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41199751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This commentary examines three critical therapeutic questions that arise for all patients, particularly for patients with psychiatric illness. These questions involve fearing death, forgiving oneself for past acts, and disclosing medical and psychiatric conditions to others. These questions, which can be critical to providing optimal medical care in some contexts, are prompted by the movie White Noise, as it might provoke questions regarding death and self-disclosure in patients. Specific responses that might be helpful to patients are offered.
{"title":"<i>White Noise</i> and Questions Regarding Death Anxiety, Forgiveness, and Patient Self-disclosure.","authors":"Edmund Howe","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This commentary examines three critical therapeutic questions that arise for all patients, particularly for patients with psychiatric illness. These questions involve fearing death, forgiving oneself for past acts, and disclosing medical and psychiatric conditions to others. These questions, which can be critical to providing optimal medical care in some contexts, are prompted by the movie <i>White Noise</i>, as it might provoke questions regarding death and self-disclosure in patients. Specific responses that might be helpful to patients are offered.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 7-9","pages":"27-29"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10561986/pdf/icns_20_7-9_27.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41199747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lifestyle medicine is a new paradigm that shifts much of the responsibility toward the patient. There is increasing evidence that healthy lifestyle interventions can be effective treatment adjuncts for some of the most common mental illnesses. This article gives examples of how to integrate evidence-based, healthy lifestyle interventions into the overall treatment of common psychiatric conditions, including anxiety and posttraumatic stress disorder (PTSD).
{"title":"Healthy Lifestyle Interventions Augmenting Psychotherapy in Anxiety and PTSD.","authors":"Terry Correll, Julie Gentile, Andrew Correll","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Lifestyle medicine is a new paradigm that shifts much of the responsibility toward the patient. There is increasing evidence that healthy lifestyle interventions can be effective treatment adjuncts for some of the most common mental illnesses. This article gives examples of how to integrate evidence-based, healthy lifestyle interventions into the overall treatment of common psychiatric conditions, including anxiety and posttraumatic stress disorder (PTSD).</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 7-9","pages":"18-26"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10561983/pdf/icns_20_7-9_18.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41199750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: Compared to the general population, the risk of suicide is three times higher in patients with epilepsy and remains doubled for these patients even after adjusting for sociodemographic correlates of suicide in the absence of mental health comorbidities. Following the United States (US) Food and Drug Administration (FDA) alert prompting a black box warning regarding the association between suicidality and antiepileptic drugs (AEDs), several studies were conducted, the results of which have been ambiguous, with some demonstrating a positive association between suicidality and AEDs, while others did not. This systematic review of literature sought to study the relationship between suicidality and AEDs when used exclusively for treatment of epilepsy.
Methods: A comprehensive literature search was conducted on PubMed without time limits using a predefined search language. The search results were then subjected to a systematic screening process. Eight out of a total of 443 articles satisfying predefined inclusion and exclusion criteria were included in the review for final data extraction.
Results: Three studies found a significant association between suicide-related behavior and levetiracetam use in the treatment of epilepsy. One study reported a positive association of pregabalin use in patients with epilepsy under 40 years of age and high AED load with suicidality, independent of depression. The remaining four studies reported a significant association between positive family and personal history of psychiatric comorbidities and suicidality in epilepsy.
Conclusion: Although there were several methodological limitations, this review found an association between levetiracetam use and mental health comorbidities and the occurrence of suicidality in epilepsy. Larger prospective, randomized studies that overcome the limitations of current studies are required to provide definitive evidence on the occurrence of suicidality in patients with epilepsy and AED use.
{"title":"Exploring the Complex Relationship Between Antiepileptic Drugs and Suicidality: A Systematic Literature Review.","authors":"Aksha M Memon, Jigar Katwala, Clarice Douille, Caitlin Kelley, Varun Monga","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>Compared to the general population, the risk of suicide is three times higher in patients with epilepsy and remains doubled for these patients even after adjusting for sociodemographic correlates of suicide in the absence of mental health comorbidities. Following the United States (US) Food and Drug Administration (FDA) alert prompting a black box warning regarding the association between suicidality and antiepileptic drugs (AEDs), several studies were conducted, the results of which have been ambiguous, with some demonstrating a positive association between suicidality and AEDs, while others did not. This systematic review of literature sought to study the relationship between suicidality and AEDs when used exclusively for treatment of epilepsy.</p><p><strong>Methods: </strong>A comprehensive literature search was conducted on PubMed without time limits using a predefined search language. The search results were then subjected to a systematic screening process. Eight out of a total of 443 articles satisfying predefined inclusion and exclusion criteria were included in the review for final data extraction.</p><p><strong>Results: </strong>Three studies found a significant association between suicide-related behavior and levetiracetam use in the treatment of epilepsy. One study reported a positive association of pregabalin use in patients with epilepsy under 40 years of age and high AED load with suicidality, independent of depression. The remaining four studies reported a significant association between positive family and personal history of psychiatric comorbidities and suicidality in epilepsy.</p><p><strong>Conclusion: </strong>Although there were several methodological limitations, this review found an association between levetiracetam use and mental health comorbidities and the occurrence of suicidality in epilepsy. Larger prospective, randomized studies that overcome the limitations of current studies are required to provide definitive evidence on the occurrence of suicidality in patients with epilepsy and AED use.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 7-9","pages":"47-51"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10561982/pdf/icns_20_7-9_47.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41199749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Migraine is a common neurovascular disorder with a pathophysiology related to the serotonin (5-hydroxytryptamine; 5-HT) system. Pharmacologic modulation of 5-HT receptors has demonstrated efficacy in the acute treatment of migraines. Psilocybin, a classic psychedelic with 5-HT receptor activity, has demonstrated therapeutic potential in the management of neuropsychiatric conditions. To date, no reports have investigated the effect of psilocybin administered acutely during a migraine episode.
Case presentation: The case of a 33-year-old male patient with a history of migraines with aura, who had acute administration of oral psilocybin (in the form of the dried fruiting body of Psilocybe cubensis mushrooms) at migraine onset is presented. Headache intensity was rated hourly using the Numerical Rating Scale (NRS) and compared to three previous migraines. Profound reductions in headache intensity and emetic episodes were reported during the migraine treated acutely with oral psilocybin administration, compared to three previous migraines.
Discussion: The severe, disabling, and treatment-resistant nature of migraines warrants continued surveillance for novel pharmacologic interventions. The established congruous pathophysiology of migraine and pharmacology of psilocybin, via the 5-HT receptor system, positions psilocybin as a potential therapeutic target.
Conclusion: While this report highlights the potential role of psilocybin in the acute management of migraines, it is essential to note that it should not be considered a basis for guiding clinical practice at this point. Further research is necessary to establish the safety and efficacy of psilocybin as a treatment option for migraines.
{"title":"Self-administration of Psilocybin for the Acute Treatment of Migraine: A Case Report.","authors":"David Wyndham Lawrence","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Migraine is a common neurovascular disorder with a pathophysiology related to the serotonin (5-hydroxytryptamine; 5-HT) system. Pharmacologic modulation of 5-HT receptors has demonstrated efficacy in the acute treatment of migraines. Psilocybin, a classic psychedelic with 5-HT receptor activity, has demonstrated therapeutic potential in the management of neuropsychiatric conditions. To date, no reports have investigated the effect of psilocybin administered acutely during a migraine episode.</p><p><strong>Case presentation: </strong>The case of a 33-year-old male patient with a history of migraines with aura, who had acute administration of oral psilocybin (in the form of the dried fruiting body of <i>Psilocybe cubensis</i> mushrooms) at migraine onset is presented. Headache intensity was rated hourly using the Numerical Rating Scale (NRS) and compared to three previous migraines. Profound reductions in headache intensity and emetic episodes were reported during the migraine treated acutely with oral psilocybin administration, compared to three previous migraines.</p><p><strong>Discussion: </strong>The severe, disabling, and treatment-resistant nature of migraines warrants continued surveillance for novel pharmacologic interventions. The established congruous pathophysiology of migraine and pharmacology of psilocybin, via the 5-HT receptor system, positions psilocybin as a potential therapeutic target.</p><p><strong>Conclusion: </strong>While this report highlights the potential role of psilocybin in the acute management of migraines, it is essential to note that it should not be considered a basis for guiding clinical practice at this point. Further research is necessary to establish the safety and efficacy of psilocybin as a treatment option for migraines.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 7-9","pages":"37-39"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10561985/pdf/icns_20_7-9_37.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41199767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joan Busner, Gahan Pandina, Simon Day, Atul Mahableshwarkar, Lucas Kempf, Maria Sheean, Judith Dunn
This article expands on a session, titled "Patient Centricity: Design and Conduct of Clinical Trials in Orphan Diseases," that was presented as part of a two-day meeting on Pediatric Drug Development at the International Society for Central Nervous System (CNS) Clinical Trials and Methodology (ISCTM) Autumn Conference in Boston, Massachusetts, in October 2020. Speakers from various areas of pediatric drug development addressed a variety of implications of including children in drug development programs, including implications for rare/orphan diseases. The speakers have written summaries of their talks. The session's lead Chair was Dr. Joan Busner, who wrote introductory and closing comments. Dr. Simon Day, regulatory consultant, outlined some of the past mistakes that have plagued trials that did not consult with patient groups in the early design phase. Dr. Atul Mahableshwarkar provided an industry perspective of a recent trial that benefited from the inclusion of patient input. Drs. Lucas Kempf and Maria Sheean provided regulatory input from the perspectives of the United States (US) Food and Drug Administration (FDA) and European Medicines Agency (EMA), respectively. Dr. Judith Dunn outlined a novel approach for assessing and rank ordering patient and clinician clinical meaningfulness and the disconnect that may occur. Dr. Busner provided closing comments, tied together the presented issues, and provided a synopsis of the lively discussion that followed the session. In addition to the speakers above, the discussion included two representatives from patient advocacy groups, as well as an additional speaker who described the challenges of conducting a pediatric trial in the US and European Union (EU), given the often competing regulatory requirements. This article should serve as an expert-informed reference to those interested and involved in CNS drug development programs that are aimed at children and rare diseases and seek to ensure a patient-centric approach.
{"title":"Patient Centricity: Design and Conduct of Clinical Trials in Orphan Diseases: Third of Three Sets of Expanded Proceedings from the 2020 ISCTM Autumn Conference on Pediatric Drug Development.","authors":"Joan Busner, Gahan Pandina, Simon Day, Atul Mahableshwarkar, Lucas Kempf, Maria Sheean, Judith Dunn","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article expands on a session, titled \"Patient Centricity: Design and Conduct of Clinical Trials in Orphan Diseases,\" that was presented as part of a two-day meeting on Pediatric Drug Development at the International Society for Central Nervous System (CNS) Clinical Trials and Methodology (ISCTM) Autumn Conference in Boston, Massachusetts, in October 2020. Speakers from various areas of pediatric drug development addressed a variety of implications of including children in drug development programs, including implications for rare/orphan diseases. The speakers have written summaries of their talks. The session's lead Chair was Dr. Joan Busner, who wrote introductory and closing comments. Dr. Simon Day, regulatory consultant, outlined some of the past mistakes that have plagued trials that did not consult with patient groups in the early design phase. Dr. Atul Mahableshwarkar provided an industry perspective of a recent trial that benefited from the inclusion of patient input. Drs. Lucas Kempf and Maria Sheean provided regulatory input from the perspectives of the United States (US) Food and Drug Administration (FDA) and European Medicines Agency (EMA), respectively. Dr. Judith Dunn outlined a novel approach for assessing and rank ordering patient and clinician clinical meaningfulness and the disconnect that may occur. Dr. Busner provided closing comments, tied together the presented issues, and provided a synopsis of the lively discussion that followed the session. In addition to the speakers above, the discussion included two representatives from patient advocacy groups, as well as an additional speaker who described the challenges of conducting a pediatric trial in the US and European Union (EU), given the often competing regulatory requirements. This article should serve as an expert-informed reference to those interested and involved in CNS drug development programs that are aimed at children and rare diseases and seek to ensure a patient-centric approach.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 1-3","pages":"25-31"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10132279/pdf/icns_20_1-3_25.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9745191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Music is an auditory stimulus of a complex nature, as many perceptive processes develop simultaneously in various areas of the brain. The same brain areas are involved in processing music and movement rhythms, which is why music can be used in the rehabilitation of movement disorders. There is growing evidence that music-assisted treadmill training can be effective in treating Parkinson's disease (PD) gait disorders, as auditory cueing with treadmill training may specifically work on those motor areas, including the cerebellum, that are not affected by the disease. Thus, music-therapy, when properly applied, could pave the way for better management of motor symptoms in PD.
{"title":"Music in Parkinson's Disease Rehabilitation: Are We Heading in the Right Direction?","authors":"Nicola Fiorente, Rocco Salvatore Calabrò","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Music is an auditory stimulus of a complex nature, as many perceptive processes develop simultaneously in various areas of the brain. The same brain areas are involved in processing music and movement rhythms, which is why music can be used in the rehabilitation of movement disorders. There is growing evidence that music-assisted treadmill training can be effective in treating Parkinson's disease (PD) gait disorders, as auditory cueing with treadmill training may specifically work on those motor areas, including the cerebellum, that are not affected by the disease. Thus, music-therapy, when properly applied, could pave the way for better management of motor symptoms in PD.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 4-6","pages":"11-13"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10306373/pdf/icns_20_4-6_11.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9729075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gahan Pandina, Joan Busner, Joseph P Horrigan, Christine McSherry, Alison Bateman-House, Luca Pani, Judith Kando
This article expands upon a session, titled "Implications of Pediatric Initiatives on CNS Drug Development for All Ages-2020 and Beyond," that was presented as part of a two-day meeting on pediatric drug development at the International Society for Central Nervous System (CNS) Clinical Trials and Methodology (ISCTM) Autumn Conference in Boston, Massachusetts, in October 2020. Speakers from various areas of pediatric drug development addressed a variety of implications of including children in drug development programs. The speakers wrote summaries of their talks, which are included here. The session's lead chair was Dr. Gahan Pandina, who wrote introductory and closing comments. Dr. Joseph Horrigan addressed the current landscape of pediatric development programs. Dr. Gahan Pandina addressed how the approach to research in pediatric populations affects the drug development process and vice versa. Dr. Alison Bateman-House discussed the ethical implications of research in the pediatric population. Dr. Luca Pani discussed some of the global regulatory issues and challenges concerning research in pediatric patients. Dr. Judith Kando served as a discussant and posed new questions about means of facilitating pediatric research. Finally, Dr. Gahan Pandina provided closing comments and tied together the presented issues. This paper should serve as an expert-informed reference to those interested and involved in CNS drug development programs that are aimed at children and/or required, through regulations, to include children as part of the approval process.
{"title":"Implications of Pediatric Initiatives on CNS Drug Development for All Ages-2020 and Beyond: Second of Three Sets of Expanded Proceedings from the 2020 ISCTM Autumn Conference on Pediatric Drug Development.","authors":"Gahan Pandina, Joan Busner, Joseph P Horrigan, Christine McSherry, Alison Bateman-House, Luca Pani, Judith Kando","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article expands upon a session, titled \"Implications of Pediatric Initiatives on CNS Drug Development for All Ages-2020 and Beyond,\" that was presented as part of a two-day meeting on pediatric drug development at the International Society for Central Nervous System (CNS) Clinical Trials and Methodology (ISCTM) Autumn Conference in Boston, Massachusetts, in October 2020. Speakers from various areas of pediatric drug development addressed a variety of implications of including children in drug development programs. The speakers wrote summaries of their talks, which are included here. The session's lead chair was Dr. Gahan Pandina, who wrote introductory and closing comments. Dr. Joseph Horrigan addressed the current landscape of pediatric development programs. Dr. Gahan Pandina addressed how the approach to research in pediatric populations affects the drug development process and vice versa. Dr. Alison Bateman-House discussed the ethical implications of research in the pediatric population. Dr. Luca Pani discussed some of the global regulatory issues and challenges concerning research in pediatric patients. Dr. Judith Kando served as a discussant and posed new questions about means of facilitating pediatric research. Finally, Dr. Gahan Pandina provided closing comments and tied together the presented issues. This paper should serve as an expert-informed reference to those interested and involved in CNS drug development programs that are aimed at children and/or required, through regulations, to include children as part of the approval process.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 1-3","pages":"18-24"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10132276/pdf/icns_20_1-3_18.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9745190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}