[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583236":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":41,"locations":51,"responsibleParty":65,"collaborators":32,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":32,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":53,"whyStopped":32,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Neuro-Behavioral Therapy","EXPERIMENTAL","Participants will receive neuro-behavioral therapy (NBT), in individual, weekly, one-hour appointments, using the 12 session, \"Taking Control of Your Functional Movements: Workbook\", over the course of 12 to 18 weeks.\n\nBefore each appointment, participants will complete worksheets\u002Fquestions in one chapter that will be discussed during the weekly virtual appointment. Video appointments will be completed using an encrypted healthcare weblink and will be digitally recorded for review to ensure therapy adherence and competence. Participants randomized to the NBT arm will also participate in 5 in-person visits for exam documentation.",[13],"Behavioral: Neuro-behavioral Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Medical Care","ACTIVE_COMPARATOR","If randomized to this treatment arm, participants will continue to follow up with their clinicians while receiving standard medical care (SMC) and without receiving the study intervention. Research staff will ask about what care participants are receiving when they meet with staff. Subjects randomized to the SMC arm will participate in 5 in-person visits for exam and SMC documentation.",[19],"Other: Standard Medical Care (SMC)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Neuro-behavioral Therapy","Neuro-behavioral therapy (NBT) is an evidence-based, multi-modality, time-limited, whole-person therapy, delivered in one hour, weekly, individual appointments. NBT has been used to treat epilepsy, nonepileptic (functional) seizures, and motor functional neurological disorder (mFND).",[9],[27],"Taking Control of Your Functional Motor Disorder Workbook",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Standard Medical Care (SMC)","Standard Medical Care (SMC) involves the routine care received by the participant. SMC may include any of the following evaluation and followup appointments with neurology, physiatry, psychiatry, psychology, mental health, rehabilitation (e.g., Physical Therapy, Occupational Therapy, Speech and Language Therapy), primary care, among other specialists.",[15],null,[34,38],{"name":35,"affiliation":36,"role":37},"W. Curt LaFrance Jr, MD, MPH","Brown University Health","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":36,"role":40},"Emily Weisbach, MD","STUDY_CHAIR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":32,"email":46},"Alexis Sr. Clinical Research Assistant","CONTACT","401-606-4651","ademarco@brownhealth.org",{"name":48,"role":44,"phone":49,"phoneExt":32,"email":50},"Deepica Clinical Research Program Coordinator","401-606-4655","dchaudhary@brownhealth.org",[52],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":32},"RECRUITING","Providence","Rhode Island","02903","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-71.41283,41.82399,{"lat":63,"lon":62},{"type":37,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"W. Curt LaFrance Jr., MD, MPH","Professor \u002F Principal Investigator","100583236","pilot-neurobehavioral-therapy-for-functional-neurological-disorder-100583236",false,"NCT06873698","Pilot Neurobehavioral Therapy for Functional Neurological Disorder","A Pilot Randomized Controlled Trial (RCT) of Neurobehavioral Therapy (NBT) Vs Standard Medical Care (SMC) for Functional Neurological Disorder (FND)","NBT for mFND","Inclusion Criteria:\n\n* Individuals diagnosed with Motor Functional Neurological Disorder (mFND)\n* Individuals aged 18-70 years\n* At least 1 mFND symptom during the year prior to enrollment\n\nExclusion Criteria:\n\n* Current or past year self-injurious behavior\n* Current suicidality (PHQ-9 question 9 rated as 1 or above)\n* Current or past year psychosis\n* Pending litigation or current application for long term disability\n* Active substance or alcohol use disorders (dependence), at the discretion of the investigator if they preclude participation in the study\n* Serious illness requiring systemic treatment or hospitalization; the participant either completes therapy or is clinically stable on therapy, for at least 30 days prior to study entry\n* Inability to fill out the self-report surveys\n* Inability or unwillingness to participate in NBT and assigned homework\n* Currently enrolled in NBT aimed at mFND","ALL","18 Years","70 Years",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[84],"NA","The goal of this pilot randomized clinical trial is to learn if Neurobehavioral Therapy (NBT) works to treat motor functional neurological disorder (mFND) (also referred to as functional motor disorder).\n\nThe main questions it aims to answer are:\n\n* Does NBT lower mFND symptoms?\n* Does NBT lower common co-occurring symptoms and improve functioning?\n\nResearchers will compare NBT to standard medical care (SMC).\n\nParticipants will be randomized to receive either:\n\n* 12 weekly sessions of NBT, along with their SMC,\n* or continue receiving their SMC as provided by their treating clinicians.\n* all participants. regardless of group assignment, will complete a total of five in-clinic visits at the following time points: Baseline, 6 weeks, 12 weeks, 8 Months and 12 Months for self-report surveys to assess functional status, quality of life and mFND symptoms.",[87],"Functional Neurological Disorder",[89,90,91,92,93,94,95,96,97],"mFND","Conversion Disorder","Functional Neurologic Disorder","Neurobehavioral Therapy","FND","Psychogenic Movement Disorder","Psychotherapy","motor functional neurological disorder","functional motor disorder","2025-03-26",{"date":100,"type":101},"2025-04-01","ACTUAL",{"date":103,"type":101},"2024-09-25",{"date":105,"type":81},"2028-06",{"name":5,"class":6},1]