Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth 1 and are associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, peer victimization, and a fourfold increased risk of suicide compared to the general population. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients. However, in these trials, only 52% of children and 38% of adults showed clinically meaningful tic improvement, meaning that 50-60% of patients do not benefit from CBIT. CBIT success relies on an ability to suppress tics that many youth lack. The central aim of CBIT is to enhance voluntary tic suppression. Better tic suppression ability drives CBIT improvement 10 and predicts lower tic burden over the course of illness. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. However, research shows that many youth lack this fundamental tic suppression ability that CBIT aspires to enhance. This study will examine the clinical and neural effects of a treatment combining Comprehensive Behavioral Intervention for Tics (CBIT) and transcranial magnetic stimulation (TMS) to the supplementary motor area (SMA) in young people with tic disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
60
10 daily sessions of CBIT plus cTBS, with MRI, behavioral, and clinical assessments before and after treatment and at 1-, 3-, and 6-month follow-ups.
10 daily sessions of CBIT plus sham cTBS, with MRI, behavioral, and clinical assessments before and after treatment and at 1-, 3-, and 6-month follow-ups.
University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGTic severity
Yale Global Tic Severity Scale, YGTSS: Gold-standard, clinician-administered tic severity scale. Includes symptom checklist of specific tic types.
Time frame: pretreatment, 10days, 1,3,6 months
Tic Suppression Task
Direct observation measure of tic suppression ability. In this paradigm, a participant is seated alone in a room in front of a computer capturing a video recording of tic occurrences for later coding by independent raters. TST will consist of two 3-min conditions: 1) free-to-tic (FT): youth is instructed to stay seated and tic freely, a measure of naturally occurring tic frequency (tics per minute); 2) suppression: youth is instructed to suppress tics. Videos will be coded to establish tic frequencies using a computerized behavioral coding program.
Time frame: pretreatment, 10days, 1,3,6 months
Tic symptoms severity
Parent/Adult Tic Questionnaire : Adult-self or parent-report measure of tic symptoms and severity
Time frame: pretreatment, 10days, 1,3,6 months
Premonitory Urge for Tics Scale
Self-report measure of intensity of urges to tic
Time frame: pretreatment, 10days, 1,3,6 months
Emotional and Behavioral functioning
Child/Adult Behavior Checklist: Parent- or adult-self report measuring broad emotional and behavioral functioning
Time frame: pretreatment, 3,6 months
Self- and parent measure of functional impairment
Patient-Reported Outcomes Measurement Information System (PROMIS-49)
Time frame: pretreatment, 10days, 1,3,6 months
Behavior Rating Inventory of Executive Function
Self- and parent-rated measure of impairment of executive function. Raw scores are converted into standardized T-scores with a mean of 50 and standard deviation of 10, higher scores reflect greater symptom severity.
Time frame: pretreatment, 1,3,6 months
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