Gahan J Pandina, Joan Busner, Lucas Kempf, Joan Fallon, Larry D Alphs, Maria T Acosta, Anna-Karin Berger, Simon Day, Judith Dunn, Victoria Villalta-Gil, Margaret C Grabb, Joseph P Horrigan, William Jacobson, Judith C Kando, Thomas A Macek, Manpreet K Singh, Arielle D Stanford, Silvia Zaragoza Domingo
{"title":"Ensuring Stakeholder Feedback in the Design and Conduct of Clinical Trials for Rare Diseases: ISCTM Position Paper of the Orphan Disease Working Group.","authors":"Gahan J Pandina, Joan Busner, Lucas Kempf, Joan Fallon, Larry D Alphs, Maria T Acosta, Anna-Karin Berger, Simon Day, Judith Dunn, Victoria Villalta-Gil, Margaret C Grabb, Joseph P Horrigan, William Jacobson, Judith C Kando, Thomas A Macek, Manpreet K Singh, Arielle D Stanford, Silvia Zaragoza Domingo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The 1983 Orphan Drug Act in the United States (US) changed the landscape for development of therapeutics for rare or orphan diseases, which collectively affect approximately 300 million people worldwide, half of whom are children. The act has undoubtedly accelerated drug development for orphan diseases, with over 6,400 orphan drug applications submitted to the US Food and Drug Administration (FDA) from 1983 to 2023, including 350 drugs approved for over 420 indications. Drug development in this population is a global and collaborative endeavor. This position paper of the International Society for Central Nervous System Clinical Trials and Methodology (ISCTM) describes some potential best practices for the involvement of key stakeholder feedback in the drug development process. Stakeholders include advocacy groups, patients and caregivers with lived experience, public and private research institutions (including academia and pharmaceutical companies), treating clinicians, and funders (including the government and independent foundations). The authors articulate the challenges of drug development in orphan diseases and propose methods to address them. Challenges range from the poor understanding of disease history to development of endpoints, targets, and clinical trials designs, to finding solutions to competing research priorities by involved parties.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"21 1-3","pages":"52-60"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10941866/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143344","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}
{"title":"The Catastrophic Perception of Pain in Burning Mouth Syndrome May be Associated with Sympathetic Tone as Indicated by the QTc Interval.","authors":"Takahiko Nagamine, Takeshi Watanabe","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"21 1-3","pages":"8-9"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10941860/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143351","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}
{"title":"ChatGPT and Transcranial Direct Current Stimulation for Chronic Pain.","authors":"Edson Silva-Filho, Rodrigo Pegado","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>We aimed to open a discussion about the integration of artificial intelligence (AI) in science and clinical practice, specifically with regard to the use of transcranial direct current stimulation (tDCS) as a technique for managing chronic pain.</p><p><strong>Main points of discussion: </strong>To analyze the responses generated by ChatGPT and the best literature about tDCS, we formulated three questions. The answers from ChatGPT, compared to the guidelines and Cochrane review, showed that AI can be a potential strategy to help clinicians and researchers. AI such as ChatGPT is revolutionizing the academic field and clinical practice. However, there is still an unmet scientific and clinical discussion about the insertion of AI to help researchers and clinicians in the neuromodulation area treat chronic pain.</p><p><strong>Conclusion: </strong>We need to know the limits of the use of AI. Even though ChatGPT might be helpful, it should be used with caution in the academic field and clinical practice.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"21 1-3","pages":"61-62"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10941863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143306","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}
{"title":"Health Anxiety, Fear of COVID-19, Nosophobia, and Health-protective Behaviors Among Healthcare Professionals.","authors":"Uzma Ilyas, Farwa Aslam, Muqadas Fatima, Zarmin Tariq, Usman Hotiana","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>This study examined fear of COVID-19, nosophobia, health anxiety, and health-protective behaviors among healthcare professionals during the COVID-19 pandemic.</p><p><strong>Methods: </strong>A cross-sectional, correlational research design was used in this study. The data of healthcare professionals (N=300) from three disciplines of medicine (Bachelor of Medicine and Bachelor of Surgery [MBBS], Bachelor of Dental Surgery [BDS], Doctor of Physiotherapy [DPT]) were collected using a purposive sampling technique. The Fear of COVID-19 Scale (FCV-19S), Medical Student Disease Perception and Distress Scale (MSD), Short Health Anxiety Inventory (SHAI), and Health Protective Behavior Scale (HBPS) were used as assessment measures. Statistical Package of Social Sciences (SPSS) version 22 was used to analyze the data obtained.</p><p><strong>Results: </strong>Of the 300 participants, 132 (44%) were male and 168 (56%) were female. A total of 199 participants (63.3%) had a MBBS degree, 59 (19.7%) had a BDS degree, and 41 (14%) had a DPT degree. The findings revealed a significant positive correlation between nosophobia, health anxiety, and fear of COVID-19, whereas health-protective behavior showed a negative association with health anxiety. Sex, health anxiety, and nosophobia were significant predictors of health-protective behaviors among medical professionals.</p><p><strong>Conclusion: </strong>The fear related to COVID-19 is associated with nosophobia and health anxiety among medical professionals, which has a substantial impact on health, work performance, and vulnerability to developing psychological distress if left unmonitored.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"21 1-3","pages":"31-35"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10941862/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143347","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}
{"title":"Morphological and Functional Changes of Cerebral Cortex in Autism Spectrum Disorder.","authors":"Leong Tung Ong, Si Wei David Fan","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder characterized by early-onset impairments in socialization, communication, repetitive behaviors, and restricted interests. ASD exhibits considerable heterogeneity, with clinical presentations varying across individuals and age groups. The pathophysiology of ASD is hypothesized to be due to abnormal brain development influenced by a combination of genetic and environmental factors. One of the most consistent morphological parameters for assessing the abnormal brain structures in patients with ASD is cortical thickness. Studies have shown changes in the cortical thickness within the frontal, temporal, parietal, and occipital lobes of individuals with ASD. These changes in cortical thickness often correspond to specific clinical features observed in individuals with ASD. Furthermore, the aberrant brain anatomical features and cortical thickness alterations may lead to abnormal brain connectivity and synaptic structure. Additionally, ASD is associated with cortical hyperplasia in early childhood, followed by a cortical plateau and subsequent decline in later stages of development. However, research in this area has yielded contradictory findings regarding the cortical thickness across various brain regions in ASD.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 10-12","pages":"40-47"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10773605/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139402682","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}
{"title":"RISK MANAGEMENT: Pop Quiz.","authors":"Donna Vanderpool","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This ongoing column is dedicated to providing information to our readers on managing legal risks associated with medical practice. We invite questions from our readers. The answers are provided by PRMS (www.prms.com), a manager of medical professional liability insurance programs with services that include risk management consultation and other resources offered to health care providers to help improve patient outcomes and reduce professional liability risk. The answers published in this column represent those of only one risk management consulting company. Other risk management consulting companies or insurance carriers might provide different advice, and readers should take this into consideration. The information in this column does not constitute legal advice. For legal advice, contact your personal attorney. Note: The information and recommendations in this article are applicable to physicians and other health care professionals so \"clinician\" is used to indicate all treatment team members.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 10-12","pages":"48"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10773598/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139402685","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}
{"title":"Whether Telerehabilitation is Actually Beneficial in Iatrogenic Facial Palsy Needs to be Confirmed by Prospective, Multicenter, Controlled Studies.","authors":"Josef Finsterer, Fulvio A Scorza","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 10-12","pages":"8"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10773603/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139402725","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}
{"title":"RISK MANAGEMENT: Pop Quiz Answers.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 10-12","pages":"55"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10773602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139402684","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}
{"title":"Left Ventricular Noncompaction Cardiomyopathy Diagnosis in a Patient Presenting with Epileptic Seizure: A \"Double-edged Sword\".","authors":"Eirini Beneki, Kyriakos Dimitriadis, Konstantinos Tsatiris, Konstantina Aggeli, Konstantinos Tsioufis","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Transient loss of consciousness (TLOC) is a common presentation to emergency departments and may be due to syncope or epileptic seizures. The distinction between both entities can be challenging. This case illustrates the need for a multidisciplinary team approach in TLOC to avoid misdiagnosis leading to improper treatment.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 10-12","pages":"9-11"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10773597/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139402681","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}
Sydnee Akubuiro, Wendy Clay, Suzie Nelson, Allison E Cowan
{"title":"Addressing Structural Racism in Child and Adolescent Psychiatry in Psychotherapy.","authors":"Sydnee Akubuiro, Wendy Clay, Suzie Nelson, Allison E Cowan","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The increase in mental health issues among children and adolescents has been declared a health crisis in the United States, and recent increases in key measures (e.g., self-harm and suicidal behaviors) have been found to disproportionately impact youth from minority backgrounds. Access to mental health treatment for youth is limited, but for minority youth, access to culturally sensitive care is even more limited. This article discusses the ways in which misdiagnosis and underdiagnosis of mental health conditions can occur in minority youth and provides key points for clinicians to consider while working with minority youth to improve mental health outcomes.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 10-12","pages":"29-34"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10773604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139402665","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}