Ben Onnink, Matthew C Correll, Andrew Correll, Terry Correll
{"title":"Psychotherapy's Role in Evaluating the Invisible Wounds of Moral Injury.","authors":"Ben Onnink, Matthew C Correll, Andrew Correll, Terry Correll","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Moral injury is a relatively new concept with varying definitions that attempts to define a profound and lasting insult to one's conscience caused by perpetration of or directly witnessing harm to another person in a high-pressure situation. This entity is separate from posttraumatic stress disorder (PTSD), but it can coexist with PTSD. This article provides psychotherapeutic examples of the diagnosis of moral injury from a psychodynamic perspective, focusing on morally challenging situations related to warfare and the healthcare system.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"21 1-3","pages":"36-42"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10941865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143349","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}
William P Horan, Gary Sachs, Dawn I Velligan, Michael Davis, Richard S E Keefe, Ni A Khin, Florence Butlen-Ducuing, Philip D Harvey
{"title":"Current and Emerging Technologies to Address the Placebo Response Challenge in CNS Clinical Trials: Promise, Pitfalls, and Pathways Forward.","authors":"William P Horan, Gary Sachs, Dawn I Velligan, Michael Davis, Richard S E Keefe, Ni A Khin, Florence Butlen-Ducuing, Philip D Harvey","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Excessive placebo response rates have long been a major challenge for central nervous system (CNS) drug discovery. As CNS trials progressively shift toward digitalization, decentralization, and novel remote assessment approaches, questions are emerging about whether innovative technologies can help mitigate the placebo response. This article begins with a conceptual framework for understanding placebo response. We then critically evaluate the potential of a range of innovative technologies and associated research designs that might help mitigate the placebo response and enhance detection of treatment signals. These include technologies developed to directly address placebo response; technology-based approaches focused on recruitment, retention, and data collection with potential relevance to placebo response; and novel remote digital phenotyping technologies. Finally, we describe key scientific and regulatory considerations when evaluating and selecting innovative strategies to mitigate placebo response. While a range of technological innovations shows potential for helping to address the placebo response in CNS trials, much work remains to carefully evaluate their risks and benefits.</p>","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"21 1-3","pages":"19-30"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10941857/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143343","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}
Mark G A Opler, Amy Claxton, James McGrory, Sabina Gasper, Meihua Wang, Sergey Yagoda
{"title":"Functioning and Cognition in Patients with Schizophrenia After Initiating Treatment with Aripiprazole Lauroxil: Secondary Outcomes and Post Hoc Analysis.","authors":"Mark G A Opler, Amy Claxton, James McGrory, Sabina Gasper, Meihua Wang, Sergey Yagoda","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Clinical practice guidelines support efforts to improve functioning in patients with schizophrenia. Discrepancies in the perception of cognitive status between clinicians, patients with schizophrenia, and their caregivers have been associated with impaired functional abilities in patients; medication side effects might worsen both cognition and daily functioning. We assessed daily/social functioning and cognition in stable patients with schizophrenia who switched to the long-acting injectable (LAI) antipsychotic aripiprazole lauroxil (AL).</p><p><strong>Methods: </strong>Clinically stable adults with residual symptoms of schizophrenia or intolerance following three or more doses of paliperidone palmitate or risperidone LAI were switched to flexibly dosed open-label AL treatment (441mg, 662mg, or 882mg every 4 weeks or 882mg every 6 weeks) for six months (ClinicalTrials.gov identifier: NCT02634320). Daily/social functioning was assessed using the Personal and Social Performance Scale (PSP); total and subscale scores were summarized using descriptive statistics. The cognitive status of patients was assessed using the New York Assessment of Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) at baseline and Month 6 or early termination, providing patient, caregiver, and clinician perspectives. A <i>post hoc</i> analysis assessed level of agreement in ratings of cognitive status among respondents, evaluated at baseline and last assessment, using weighted kappa coefficients (0.01-0.20, slight agreement; 0.21-0.40, fair agreement; 0.41-0.60, moderate agreement; 0.61-0.80, substantial agreement.).</p><p><strong>Results: </strong>All 51 enrolled patients received one or more AL doses; 35 completed the study, and 45 contributed data at last assessment. Mean age was 40.6 years; 72.5 percent of patients were male. Based on PSP total score, functioning was maintained from baseline (mean [standard deviation (SD)]: 55.1 [10.5]) through six months of AL treatment (mean [SD]: 57.7 [13.2]). Proportions of patients rating personal and social functioning issues as \"not present\" or \"mild\" remained stable between baseline and Month 6 for each PSP subscale. At baseline (n=50), cognitive difficulties were most commonly rated \"not present\" or \"mild\" in all NY-AACENT domains by patients (58-86% across domains), clinicians (62-94%), and caregivers (50-92%), and these rates were maintained or increased at last assessment for all reporters. Weighted kappa coefficients indicated fair-to-substantial agreement between patients and clinicians across domains at last assessment (0.32-0.64; baseline: 0.14-0.55); patient-caregiver agreement ranged from 0.07 to 0.50 at last assessment (baseline: 0.25-0.60).</p><p><strong>Conclusion: </strong>In clinically stable patients with schizophrenia who initiated AL, self-reported functioning was maintained over six months of treatment. Clinician-, caregiver-, and patient-reported cognitive func","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"21 1-3","pages":"43-51"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10941858/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143345","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 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}