CBIT+TMS R33 Phase

Launched by UNIVERSITY OF MINNESOTA · Nov 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for young people aged 12 to 21 who have chronic tics or Tourette Syndrome. The treatment combines a behavioral therapy called Comprehensive Behavioral Intervention for Tics (CBIT) with a technique known as transcranial magnetic stimulation (TMS), which uses magnetic pulses to stimulate specific areas of the brain. The goal is to see if this combined approach can help improve tic control better than CBIT alone, especially for those who struggle to suppress their tics.

To participate in the trial, individuals must have had tics for at least a year and have moderate to severe tic symptoms. They should also be right-handed and able to understand English. Participants can still take certain stable medications for mental health but cannot be on specific antipsychotic drugs or be involved in other treatments focused on tics. Throughout the study, participants will receive support and monitoring to ensure their safety and well-being. This trial is an important step in finding new and effective treatments for youth with tic disorders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, current pregnancy or girls of childbearing age not using effective contraception, or any other medical condition deemed serious or contraindicated by a study physician.
• • Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia)
• • Left handedness.
• • Active suicidality.
• • Previous diagnosis of psychosis or cognitive disability.
• • Substance abuse or dependence within the past year.
• • Concurrent psychotherapy focused on tics.
• • Neuroleptic/antipsychotic medications.
• • Pregnant according to the medical history or a urine pregnancy test; and menstruating individuals capable of becoming pregnant and not using a highly effective form of contraception (FDA-approved hormonal contraceptive, IUD, tubal ligation)
• • Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)