CBIT + TMS for Tics
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining two treatments, Comprehensive Behavioral Intervention for Tics (CBIT) and transcranial magnetic stimulation (TMS), can better help young people manage chronic tics. The goal is to determine if adding TMS, which uses magnetic pulses to target brain areas involved in movement, improves tic control compared to CBIT alone. This trial may suit young individuals aged 12-21 who have experienced moderate to severe motor or vocal tics for over a year. Participants must be right-handed, fluent in English, and free from certain medical conditions or specific medications.
As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in tic management.
Will I have to stop taking my current medications?
You can continue taking your current medications if they have been stable for at least 6 weeks and are expected to remain stable during the study, except for neuroleptic/antipsychotic medications, which are not allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both Comprehensive Behavioral Intervention for Tics (CBIT) and transcranial magnetic stimulation (TMS) are treatments generally well-tolerated by patients. CBIT can reduce tic symptoms in some individuals, though it may not be effective for everyone.
TMS, a non-surgical procedure, uses magnetic fields to activate nerve cells in the brain. Studies suggest it is safe, with most side effects being mild, such as headaches or scalp discomfort, which usually resolve on their own.
While specific data on using CBIT and TMS together for tics is lacking, both treatments are considered safe when used separately. This trial aims to understand their combined effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using CBIT combined with TMS for treating chronic tics because it combines a well-established behavioral therapy with an innovative brain stimulation technique. Unlike other treatments that focus solely on medication or behavior therapy, this approach uses transcranial magnetic stimulation (TMS) to target the supplementary motor area of the brain, which may directly influence tic generation. This combination could offer a non-invasive way to manage tics more effectively, potentially reducing the need for medication and its associated side effects. The inclusion of TMS, particularly theta burst stimulation, is what sets this treatment apart, offering a new mechanism of action that may enhance the benefits of traditional behavioral interventions.
What evidence suggests that this trial's treatments could be effective for chronic tics?
Research has shown that Comprehensive Behavioral Intervention for Tics (CBIT) can reduce tics in both children and adults. However, only about 52% of children and 38% of adults experience significant improvement with CBIT alone. This trial will compare two groups: one will receive CBIT combined with transcranial magnetic stimulation (TMS), and the other will receive CBIT with sham stimulation for TMS. TMS is a non-invasive treatment that uses magnetic fields to target specific brain areas. Early results suggest that TMS might enhance the brain's ability to control tics, potentially aiding those who do not fully benefit from CBIT alone.12678
Who Is on the Research Team?
Christine Conelea
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of Comprehensive Behavioral Intervention for Tics (CBIT) and transcranial magnetic stimulation (TMS) to the supplementary motor area (SMA)
Follow-up
Participants are monitored for tic severity and other outcomes using various scales
What Are the Treatments Tested in This Trial?
Interventions
- CBIT
- TMS
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor