Actively Recruiting

Phase 2
Age: 12Years - 21Years
All Genders
NCT06678737

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

Age: 12Years - 21Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

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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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