Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

Not Applicable

Completed

Conditions: Tourette Syndrome
Tic Disorder, Childhood
Tics
Tic, Motor
Tourette Syndrome in Children
Tic Disorders
Tourette Syndrome in Adolescence

Interventions: Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)
Device: Continuous Theta Burst Stimulation (cTBS)
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
CBIT + cTBS	Comprehensive Behavioral Intervention for Tics (CBIT)	Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
CBIT + rTMS	Comprehensive Behavioral Intervention for Tics (CBIT)	Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
CBIT + cTBS	Continuous Theta Burst Stimulation (cTBS)	Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
CBIT + Sham	Comprehensive Behavioral Intervention for Tics (CBIT)	Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment.
CBIT + rTMS	Repetitive Transcranial Magnetic Stimulation (rTMS)	Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).

Primary Outcome Measures

Name	Time	Method
Change in resting state fMRI connectivity of SMA-mediated brain circuits	baseline to post-treatment; approximately 10 days	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).
Change in SMA activation	baseline to post-treatment; approximately 10 days	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).

Secondary Outcome Measures

Name	Time	Method
Change in Tic Suppression Task	baseline to 3 months post-treatment	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.
Safety: Measured as Rate of Adverse Events Related to Study Treatment	approximately 3-4 months	The number of adverse events judged to be treatment related will be totaled and reported for each group.
Feasibility: Measured as Participant Treatment Completion	approximately 3-4 months	For each group, the number of participants who completed at least 80% of treatment sessions will be totaled and reported for each group.

Locations (1): University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States