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.
All participants will receive 10 daily sessions of CBIT, a well-established behavioral treatment that is considered by the American Academy of Neurology to be the first-line intervention for tics. Immediately prior to each CBIT session, participants will undergo TMS targeting the SMA. The specific type of TMS procedure will be randomly assigned between subjects and be either: 1 Hz repetitive TMS (rTMS), continuous theta burst stimulation (cTBS), or sham stimulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
CBIT is a manualized treatment program focused on tic management skills
During repetitive transcranial magnetic stimulation (rTMS), a electromagnetic coil is placed against the scalp while an electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the target brain region
During continuous theta burst stimulation (cTBS), a electromagnetic coil is placed against the while an electromagnet painlessly delivers magnetic bursts that stimulate nerve cells in the target brain region
University of Minnesota
Minneapolis, Minnesota, United States
Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits
For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d).
Time frame: baseline to post-treatment; approximately 10 days
Change in SMA Activation
For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d).
Time frame: baseline to post-treatment; approximately 10 days
Safety: Measured as Rate of Adverse Events Related to Study Treatment
The number of adverse events judged to be treatment related will be totaled and reported for each group.
Time frame: approximately 3-4 months
Change in Tic Suppression Task
The Tic Suppression Task is a clinician-rated tool for assessing tic frequency. A video recording of participant is rated and yields a score in units of tics per minute. Outcome reported as change from baseline to post treatment; change from baseline to 1 month post treatment; change from baseline to 3 months post treatment; change from post treatment to 1 month post treatment; and change from post treatment to 3 months post treatment.
Time frame: baseline to 3 months post-treatment
Feasibility: Measured as Participant Treatment Completion
For each group, the number of participants who completed at least 80% of treatment sessions will be totaled and reported for each group.
Time frame: approximately 3-4 months
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