[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657436":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":37,"studyPopulation":33,"armGroups":38,"interventions":49,"overallOfficials":55,"centralContacts":59,"locations":68,"responsibleParty":82,"collaborators":33,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":33,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":33,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":70,"whyStopped":33,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"To assess the safety and tolerability of repeated theta burst TMS administration in adolescents age 15 - 35 years with CTD.","This study's primary aim is to determine the safety and tolerability of repeated TMS administration in adolescents and adults ages 15 - 35 years with DSM-5 confirmed CTD of moderate or greater severity. These will be determined by protocol completion rate from enrollment to final visit, and tabulation of the individual and summed frequencies of reported and identified adverse events observed from study enrollment to final visit.","All protocol visits (treatment days 1 - 10)",[14],{"measure":15,"description":16,"timeFrame":17},"To examine the possible efficacy of repeated TMS administration on CTD symptom severity at two different brain regions (M1 and SMA).","The secondary objective of the project is to examine if repeated TMS administration at two different brain regions (M1 and SMA) is associated with clinically significant decreases in CTD symptom severity, as measured by repeated administration of the Yale Global Tic Severity Scale (YGTSS) by a trained clinical rater.","Screening, baseline, treatment day 5, treatment day 10, 1-week follow-up, 1-month follow-up",[19,23,26],{"measure":20,"description":21,"timeFrame":22},"Change in Clinical Global Impression-Severity Scale (CGI-S) pre- vs post-TMS","At the clinical level, the investigators will identify possible early clinical efficacy signals of accelerated cTBS in reducing tics and related symptoms. Clinical outcomes will be assessed using Clinical Global Impression-Severity Scale (CGI-S). The investigators will examine within-subject changes from baseline to post-treatment and compare response patterns across stimulation targets.","Baseline, treatment day 5, treatment day 10, 1-week follow-up, 1-month follow-up",{"measure":24,"description":25,"timeFrame":22},"Change in Clinical Global Impression-Improvement Scale (CGI-I) pre- vs post-TMS","At the clinical level, the investigators will identify possible early clinical efficacy signals of accelerated cTBS in reducing tics and related symptoms. Clinical outcomes will be assessed using Clinical Global Impression-Improvement Scale (CGI-I). The investigators will examine within-subject changes from baseline to post-treatment and compare response patterns across stimulation targets.",{"measure":27,"description":28,"timeFrame":29},"Change in functional connectivity pre- vs post-TMS","The investigators will explore whether pre-treatment fMRI features differentiate responders from non-responders, providing early insight into potential neural predictors of cTBS efficacy. Using our pre- and post-treatment resting state fMRI measures of functional connectivity between the TMS target of SMA vs M1 and other nodes, the investigators will determine if a pattern of baseline fcrsMRI activity or change over time is correlated with CTD symptom change with treatment. The investigators will conduct resting state fMRI (RS-fMRI) scans at baseline (before TMS) and one week following completion of TMS (approximately 3 weeks after baseline). The investigators will identify associations of functional connectivity using SMA and M1- thumb seeds with clinical symptom response.","From time of enrollment to one week follow up after end of treatment (Week 4)",{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":33,"timePerspective":33,"maskingInfo":35},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":36,"maskingDescription":33,"whoMasked":33},"NONE","For Aims 1 and 2, the investigators propose to test a protocol of accelerated inhibitory continuous theta burst stimulation (cTBS) targeting areas of tic-related hyperactivity as identified by functional MRI. Participants will be randomized by computerized list to either receive rTMS directed at the SMA or rTMS directed toward the M1. The investigators will examine data on tolerability, adverse events and early efficacy signals that could inform future, larger scale controlled trials for this indication in adolescents and young adults.\n\nTMS: Our protocol consists of five treatments of inhibitory continuous TBS (cTBS) with the target intensity less than 100% to the SMA or M1 Thumb (as determined by random assignment) lasting five minutes delivered over the course of 10 days (2 weeks) for a total of 50 treatments.\n\nFor Aim 3, the investigators will utilize repeated brain MRI imaging pre- and post-TMS treatment within persons with CTD to gauge direction of effects. The investigators plan to observe functional network activity in presumed tic-related neural circuits in youth with CTD pre- and post-treatment. A within-person design also highlights a personalized approach to circuit-based therapeutics that can be explored for individual differences in neural and clinical responses.\n\nMR Imaging Protocol: MRI scanning including T1-weighted anatomical and rs-fMRI will take place on a GE Discovery MR750 3 Tesla scanner. For the rs-fMRI scan, patients will be asked to undergo at least 2x 7 minute scans with eyes open and were observed by an MR technician to ensure wakefulness. All T1 and fMRI scans will be preprocessed using the fMRIprep, a standardized preprocessing pipeline which utilizes tools from the widely-used MRI processing software packages AFNI, ANTs, FreeSurfer, and FSL. T1 scans will be corrected for intensity nonuniformity, skull-stripped, and segmented for registration purposes, then resampled into MNI space. fMRI scans will be slice-time corrected and resampled back to their native space with headmotion correction, then registered and resampled to both T1 space and MNI space. Data analysis will be performed in AFNI, including denoising of fMRI data using nuisance regressors generated by fMRIprep including 12 motion parameters as well as CSF and white matter signals. The resulting residual signal will then be utilized to generate RSFC matrices from the Fisher transformed correlation to generate normalized Z statistics.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"M1 (primary motor cortex)","EXPERIMENTAL","Determine if cTBS to the M1 can reduce CTD symptoms and normalize abnormal network connectivity within the Somato-Cognitive Action Network (SCAN).",[44],"Device: cTBS (accelerated continuous theta burst stimulation)",{"label":46,"type":41,"description":47,"interventionNames":48},"SMA (supplementary motor area)","Determine if cTBS to the SMA can reduce symptoms of CTD and normalize abnormal network connectivity within the Action Mode Network (AMN).",[44],[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":33},"DEVICE","cTBS (accelerated continuous theta burst stimulation)","Participants will be randomized to receive 50 sessions of 1800 pulses of cTBS rTMS over two weeks, with five sessions\u002Fday targeting the SMA or M1.",[40,46],[56],{"name":57,"affiliation":5,"role":58},"Andrew M Lee","PRINCIPAL_INVESTIGATOR",[60,64],{"name":57,"role":61,"phone":62,"phoneExt":33,"email":63},"CONTACT","415-476-7000","AndrewMoses.Lee@ucsf.edu",{"name":65,"role":61,"phone":66,"phoneExt":33,"email":67},"James T McCracken","415-514-5743","James.Mccracken@ucsf.edu",[69],{"facility":5,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":33},"RECRUITING","San Francisco","California","94107","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-122.41942,37.77493,{"lat":80,"lon":79},{"type":83,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100657436","teen-and-adult-tic-tms-study-100657436",false,"NCT07839377","Teen and Adult Tic TMS Study","Treating Adolescent and Adult Tic Disorders With Transcranial Magnetic Stimulation","Inclusion Criteria:\n\n1. Outpatients\n2. Ages 15 - 35 years old\n3. Meets DSM-5 criteria for persistent (chronic) vocal\u002Fmotor tic disorder or Tourette's syndrome with screening YGTSS score ≥ 20 (moderate or greater severity).\n4. Moderate severity or intolerable side effects with at least one prior trial of an evidence-based anti-tic medication.\n5. Stable on chronic psychotropic medications and\u002For therapy for 6 weeks prior to the study and agreeable to continue current treatments without change throughout the study.\n6. Participants may continue to take medications and record daily usage throughout the study.\n7. Capacity to provide informed assent or consent and parent or legal guardian able to provide consent for minors.\n8. Ability to tolerate clinical study procedures.\n9. Successfully complete the screening forms without any contraindications.\n\nExclusion Criteria:\n\n1. Psychiatric: history of schizophrenia, bipolar disorder, substance \u002Falcohol abuse disorder, current elevated suicide risk, prior psychosurgery.\n2. Neurologic: severe neurocognitive disorder, seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, TBI, hydrocephalus, sequelae of meningitis, frank brain injury).\n3. TMS contraindications: implanted device; presence of metal in the head, including eyes and ears (excluding dental implants); certain tics.\n4. Subjects with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension; malnutrition).\n5. Females who are pregnant or nursing (as determined by a questionnaire and urine pregnancy test).\n6. Inability to complete the research protocol as determined by the Principal Investigator.","ALL","15 Years","35 Years",{"count":95,"type":96},40,"ESTIMATED","INTERVENTIONAL",[99],"NA","This project investigates safety, tolerability, and efficacy signals of accelerated continuous theta burst stimulation (cTBS), a form of inhibitory repetitive transcranial magnetic stimulation (rTMS), for patients with Tourette Syndrome and chronic tic disorders (CTD). It integrates resting-state functional MRI (fMRI) to assess changes in brain circuits and neurophysiology. CTD are neurodevelopmental disorders marked by motor and\u002For vocal tics, associated with dysfunction in cortico-striato-thalamo-cortical (CSTC) networks, particularly the supplementary motor area (SMA), primary motor cortex (M1), and connected regions. While low-frequency rTMS has shown preliminary benefits in pediatric populations, circuit-targeted approaches remain relatively unexplored in children, adolescents and adults, leaving no consensus about optimal applications.\n\nParticipants will be randomized to receive 50 sessions of 1800 pulses of cTBS rTMS over two weeks, with five sessions\u002Fday targeting the SMA or M1. Assessments will include the Yale Global Tic Severity Scale (YGTSS) and MRI.\n\nAim 1 Determine if cTBS to the M1 can reduce CTD symptoms and normalize abnormal network connectivity within the Somato-Cognitive Action Network (SCAN).\n\nAim 2 Determine if cTBS to the SMA can reduce symptoms of CTD and normalize abnormal network connectivity within the Action Mode Network (AMN).",[102],"Tic Disorder",[104,105,106,107,108,102],"Tic","Tics","Tourette's","Tourette","Tourettes","2026-09-18",{"date":111,"type":112},"2026-09-24","ACTUAL",{"date":114,"type":112},"2026-06-01",{"date":116,"type":96},"2028-10",{"name":5,"class":6},1]