CBIT+TMS R33 Phase

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 21
Healthy Volunteers: f
View:

• Age 12-21 years at time of enrollment.

• Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.

• At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).

• Full scale IQ greater than 70.

• Child, consenting parent, and adult participant required to have English fluency and literacy to ensure comprehension of study measures and instructions.

• Right-handed

• To increase external validity of findings, we will include participants taking psychotropic medications that have been stable for 6 weeks and expect to remain stable for the approximately 3-week intervention protocol (with the exception of those taking neuroleptic/antipsychotic medications). Those who previously received tic-specific therapy will be included if they meet the tic severity criterion.

⁃ Youth receiving other forms of psychotherapy will be included provided these treatments are not focused on tics. All concurrent treatments will be monitored during the study period.

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Christine Conelea, PhD, LP
cconelea@umn.edu
612-626-3127
Time Frame
Start Date: 2025-02-27
Estimated Completion Date: 2030-07-15
Participants
Target number of participants: 60
Treatments
Experimental: Experimental group
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).
Sham_comparator: Control group
Youth with chronic tics randomized to CBIT and sham stimulation for TMS
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov