Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-26 @ 5:46 PM
Study NCT ID:
NCT05155059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-03
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003291', 'term': 'Conversion Disorder'}], 'ancestors': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05-30', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-31', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2021-12-10', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'S-FMDRS', 'timeFrame': '1 month after iTBS', 'description': 'Short version of Functional Movement Disorder Rating Scale'}], 'secondaryOutcomes': [{'measure': 'S-FMDRS', 'timeFrame': '2 and 6 months after iTBS', 'description': 'Short version of Functional Movement Disorder Rating Scale'}, {'measure': 'SF-36', 'timeFrame': '1, 2 and 6 months after iTBS', 'description': 'Health related quality of life'}, {'measure': 'CGI', 'timeFrame': '1, 2 and 6 months after iTBS', 'description': 'Clinical Global impression - scale of 1-7 to measure clinical improvement from the intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional Movement Disorders', 'Transcranial Magnetic Stimulation (TMS)', 'iTBS', 'Repetitive Transcranial Magnetic Stimulation', 'Neuroimaging', 'Conversion Disorder'], 'conditions': ['Functional Movement Disorder']}, 'referencesModule': {'references': [{'pmid': '34203993', 'type': 'BACKGROUND', 'citation': 'Spagnolo PA, Parker J, Horovitz S, Hallett M. Corticolimbic Modulation via Intermittent Theta Burst Stimulation as a Novel Treatment for Functional Movement Disorder: A Proof-of-Concept Study. Brain Sci. 2021 Jun 15;11(6):791. doi: 10.3390/brainsci11060791.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_000642-N.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nFunctional movement disorders (FMD) involve involuntary movements that are not due to a recognized neurological or medical cause. FMD can cause major disability. Researchers want to learn more to create better treatments for FMD.\n\nObjective:\n\nTo test whether non-invasive brain stimulation using transcranial magnetic stimulation (TMS) improves FMD symptoms.\n\nEligibility:\n\nPeople between the ages of 18 and 80 who have been diagnosed with FMD by a neurologist.\n\nDesign:\n\nParticipants will be randomly assigned to one of two groups. One group is an active brain stimulation group and the other is a sham brain stimulation group.\n\nParticipants will have a baseline visit. This will include:\n\nNeurological exam\n\nQuestionnaires\n\nUrine test\n\nBrain MRI: Participants will lie in a machine that takes pictures of the body. They will be asked to respond to images on a screen while in the scanner.\n\nWithin 2 weeks of the baseline visit, participants will begin 5 daily sessions of TMS. The active group will have stimulation delivered to the brain via a coil. In the sham group, a dummy coil will be used that will not deliver stimulation. A total of three 3-minute cycles will be done in one visit. There will be 20-minute breaks between the cycles.\n\nParticipants will have visits 1 month, 2 months, and 6 months after their last day of TMS. Their FMD symptoms will be evaluated. They will complete health questionnaires. These visits can be in person or virtual.', 'detailedDescription': 'Study Description:\n\nThe purpose of this protocol is to investigate efficacy of intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) in patients with functional movement disorders (FMD). Participants will be randomly assigned to receive either active iTBS or sham stimulation of the left DLPFC for 5 consecutive daily sessions.\n\nObjectives:\n\nPrimary Objective: To investigate efficacy of iTBS of the left DLPFC on motor symptoms in patients with FMD\n\nSecondary Objectives: To investigate efficacy of iTBS of the left DLPFC on mood symptoms and its effect on fronto-amygdala circuit on functional neuroimaging\n\nEndpoints:\n\nPrimary Endpoint: Relative change in Functional Movement Disorder Rating Scale (S-FMDRS) from the baseline to 1 month after iTBS vs sham: 100 \\*( S-FMDRS at one-month - S-FMDRS at baseline)/ S-FMDRS at baseline\n\nSecondary Endpoints:\n\n* S-FMDRS immediately after, 2 months and 6 months after the treatment\n* HADS at 1 month, 2 months and 6 months after the treatment\n* DLPFC-amygdala functional connectivity\n* Amygdala BOLD response to emotional stimuli'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 18-80\n* Diagnosis of functional movement disorder made by a neurologist\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Current psychosis or active suicidal ideation\n* History of epilepsy with the exception of febrile seizure\n* Patients with psychogenic non-epileptic seizure without comcomitant functional movement disorder\n* Any significant neurological disorders other than FMD including but not limited to multiple sclerosis, stroke, Parkinson s disease, space occupying brain lesion\n* Alcohol or substance use disorder\n* Patients who are on Buproprion (Wellbutrin)\n* Patients with moderate to severe cardiac disease\n* Any psychiatric, medical or social condition due to which, in the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05155059', 'briefTitle': 'Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Phase II Trial of Non-Invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders', 'orgStudyIdInfo': {'id': '10000642'}, 'secondaryIdInfos': [{'id': '000642-N'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Sham TMS stimulation using a sham coil', 'interventionNames': ['Other: Sham Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Active TMS stimulation using an active TMS coil', 'interventionNames': ['Device: MagStim']}], 'interventions': [{'name': 'MagStim', 'type': 'DEVICE', 'description': 'Bursts of three at 50Hz with an inter burst interval of 200 ms will be given for 190 seconds and this session will be repeated 3 times with 20 minutes between each session in one day. The set of 3 sessions will be repeated 5 times in 5 consecutive days.', 'armGroupLabels': ['Treatment']}, {'name': 'Sham Comparator', 'type': 'OTHER', 'description': 'Sham TMS stimulation using a sham coil', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Debra J Ehrlich, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Neurological Disorders and Stroke (NINDS)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'For 2 years after the publication', 'ipdSharing': 'YES', 'description': 'All collected IPD during the trial can be shared after de-identification.', 'accessCriteria': 'IPD can be shared with researchers who provide methodologically sound proposal for meta-analysis or any other scientific analysis. Requests should be directed to the study PI who will review requests. Only de-identified data will be shared for scientific purposes.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}