Actively Recruiting
CBIT+TMS R33 Phase
Led by University of Minnesota · Updated on 2026-04-13
60
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CBIT+TMS R33 Phase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 21 years at enrollment
- Current chronic motor and/or vocal tics lasting at least 1 year without a tic-free period longer than 3 months
- Tic severity with Yale Global Tic Severity Scale total score 14 or higher (or 9 or higher for motor or vocal tics only)
- Full scale IQ greater than 70
- English fluency and literacy for child, consenting parent, and adult participant
- Stable psychotropic medications for at least 6 weeks with no planned changes during the 3-week intervention, excluding neuroleptic/antipsychotic medications
- Previous tic-specific therapy allowed if tic severity criteria are met
- Concurrent psychotherapy allowed if not focused on tics
- Willingness to undergo MRI, behavioral, and clinical assessments
You will not qualify if you...
- Medical conditions contraindicating or increasing risk with TMS, including intracranial pathology, epilepsy or seizures, brain injury or tumors, stroke, implanted medical devices or metal in the head, current pregnancy, or lack of effective contraception in girls of childbearing potential
- Inability to undergo MRI (e.g., metal implants, claustrophobia, orthodontia)
- Active suicidality
- Previous diagnosis of psychosis or cognitive disability
- Substance abuse or dependence within the past year
- Currently receiving psychotherapy focused on tics
- Use of neuroleptic or antipsychotic medications
- Pregnancy or menstruating females not using highly effective contraception
- Taking medications without stability for at least 6 weeks or with planned changes during the intervention period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
C
Christine Conelea, PhD, LP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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