60 Participants Needed

CBIT + TMS for Tics

CC
Overseen ByChristine Conelea, PhD, LP
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Minnesota
Must be taking: Psychotropic medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Research Team

CC

Christine Conelea

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for young people aged 12-21 with chronic motor and/or vocal tics, a Yale Global Tic Severity Scale score ≥14, an IQ over 70, English fluency, and right-handedness. Stable psychotropic medication use is allowed except neuroleptics/antipsychotics. Prior tic therapy recipients can join if they still have moderate tic severity.

Inclusion Criteria

I am between 12 and 21 years old.
My IQ is above 70.
I, and if applicable, my child or parent, can fluently read and understand English.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of Comprehensive Behavioral Intervention for Tics (CBIT) and transcranial magnetic stimulation (TMS) to the supplementary motor area (SMA)

10 days
Multiple visits for TMS sessions

Follow-up

Participants are monitored for tic severity and other outcomes using various scales

6 months
Assessments at 1, 3, and 6 months

Treatment Details

Interventions

  • CBIT
  • TMS
Trial Overview The study tests combining Comprehensive Behavioral Intervention for Tics (CBIT) with transcranial magnetic stimulation (TMS) to the supplementary motor area in youth with tics. It aims to improve voluntary tic suppression by comparing CBIT+cTBS against CBIT+sham cTBS.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental groupExperimental Treatment1 Intervention
Youth with chronic tics randomized to a combined treatment involving Comprehensive Behavioral Intervention for Tics (CBIT) and inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS). TMS involves theta burst stimulation (cTBS).
Group II: Control groupPlacebo Group1 Intervention
Youth with chronic tics randomized to CBIT and sham stimulation for TMS

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+
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