N/A
N=50
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics
Tic Disorders · Tics · Tic, Motor · Tic Disorder, Childhood · Tourette Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04578912 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits — 0.0312; 0.261; 0.158 eta squared
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Comprehensive Behavioral Intervention for Tics (CBIT) (Behavioral); Repetitive Transcranial Magnetic Stimulation (rTMS) (Device); Continuous Theta Burst Stimulation (cTBS) (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits |
0.0312; 0.261; 0.158 | — |
| PRIMARY Change in SMA Activation |
0.45; 0.01; 0.27 | — |
| SECONDARY Safety: Measured as Rate of Adverse Events Related to Study Treatment |
46; 22; 18 | — |
| SECONDARY Change in Tic Suppression Task |
0.58; -3.83; -8.24 | — |
| SECONDARY Feasibility: Measured as Participant Treatment Completion |
17; 15; 16 | — |
Summary
The study will examine whether combining Comprehensive Behavioral Intervention for Tics (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression ability, and enhances CBIT outcomes in young people with tic disorder. The study will also examine different TMS dosing strategies.
Eligibility Criteria
Inclusion Criteria
- Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.
- At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).
- Full scale IQ greater than or equal to 70
- English fluency to ensure comprehension of study measures and instructions.
- Right-handed
Exclusion Criteria
- Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, current pregnancy or participants of childbearing age not using effective contraception, or any other medical condition deemed serious or contraindicated by a study physician
- Inability to undergo MRI.
- Left handedness.
- Active suicidality.
- Previous diagnosis of psychosis or cognitive disability.
- Substance abuse or dependence within the past year.
- Concurrent psychotherapy focused on tics.
- Neuroleptic/antipsychotic medications.
- Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)
Data sourced from ClinicalTrials.gov (NCT04578912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.