An interventional study of cTBS (accelerated continuous theta burst stimulation) in Tic Disorder, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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/or 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.
Participants will be randomized to receive 50 sessions of 1800 pulses of cTBS rTMS over two weeks, with five sessions/day targeting the SMA or M1. Assessments will include the Yale Global Tic Severity Scale (YGTSS) and MRI.
Aim 1 Determine if cTBS to the M1 can reduce CTD symptoms and normalize abnormal network connectivity within the Somato-Cognitive Action Network (SCAN).
Aim 2 Determine if cTBS to the SMA can reduce symptoms of CTD and normalize abnormal network connectivity within the Action Mode Network (AMN).
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.
TMS: 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.
For 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.
MR 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.
102 studies on the registry are indexed under Tic Disorders; 26 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 83 interventional studies indexed under Tic Disorders.
Browse Tic Disorders studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Determine if cTBS to the M1 can reduce CTD symptoms and normalize abnormal network connectivity within the Somato-Cognitive Action Network (SCAN).
Device: cTBS (accelerated continuous theta burst stimulation)
Determine if cTBS to the SMA can reduce symptoms of CTD and normalize abnormal network connectivity within the Action Mode Network (AMN).
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/day targeting the SMA or M1.
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.
Time frame: All protocol visits (treatment days 1 - 10)
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.
Time frame: Screening, baseline, treatment day 5, treatment day 10, 1-week follow-up, 1-month follow-up
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.
Time frame: Baseline, treatment day 5, treatment day 10, 1-week follow-up, 1-month follow-up
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.
Time frame: Baseline, treatment day 5, treatment day 10, 1-week follow-up, 1-month follow-up
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.
Time frame: From time of enrollment to one week follow up after end of treatment (Week 4)
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Jun 2028, 24 months after the start.
Of 39 non-industry interventional studies with no phase under Tic Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 64. This study's planned 24 months is below that.
Counting every sponsor, half of 39 studies reached it within 28 months; a quarter within 16 and three quarters within 64.
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