NCT06678737

CBIT+TMS R33 Phase

Recruiting now Phase 2 Last updated 13 April 2026

What this trial tests

Phase 2 trial testing CBIT +cTBS in Tics in 60 participants. Currently enrolling.

Timeline

27 February 2025

Primary endpoint
15 July 2030

15 July 2030

Quick facts

Lead sponsor	University of Minnesota
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	basic science
Enrollment	60
Start date	27 February 2025
Primary completion	15 July 2030
Estimated completion	15 July 2030
Sites	1 location across United States

Drugs / interventions tested

• CBIT +cTBS
• CBIT +sham cTBS

Conditions studied

• Tics — all drugs for Tics →
• Tourette Syndrome — all drugs for Tourette Syndrome →

Sponsor

University of Minnesota

Who can join

Adults 12 to 21, any sex, with Tics or Tourette Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.