Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Nov 23, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach using a technique called intermittent theta-burst stimulation (iTBS) to help improve motor control in individuals with Tourette Syndrome (TS). Researchers believe that TS is linked to how certain brain areas communicate and function together. The goal of this study is to see if iTBS can enhance the brain's ability to control movements, which may lead to a reduction in tics, the involuntary movements or sounds that people with TS often experience.

To participate in this trial, candidates must be between 10 and 21 years old and have a confirmed diagnosis of Tourette Syndrome. They should also be stable in their current treatment, meaning no recent changes in medication or other therapies. Participants will receive either the active treatment or a placebo (a sham treatment that does not have the active ingredient) and will be closely monitored throughout the study. This research aims to find a safe and effective way to help manage Tourette Syndrome symptoms, and those interested should be comfortable communicating in English and able to understand the study details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants of any sex, race, or ethnicity meeting all criteria listed below will be included in the study:
• • 1. Aged 10-21 years
• • 2. Fluent in English
• • 3. DSM-5 diagnosis of TS, confirmed by the clinical team
• • 4. Able to participate in the informed consent process, provide voluntary informed consent/assent and provide a spontaneous narrative description of the key elements of the study.
• • 5. Clinical stability: determined by a physician, no switch of psychotropic medications or increase in dosage in the last 14 days from TMS treatment start; no change in other therapeutic interventions in last 14 days from TMS treatment start.
• Exclusion Criteria:
• • 1. Any neurodevelopmental, psychiatric condition other than TS, ADHD, or OCD, or mild anxiety based on review of K-SADS. Note - if an exclusionary psychiatric diagnosis is suspected based on K-SADS, the research physician will follow up with the parent and referral will be made to psychology or psychiatry as appropriate.
• • 2. Presence of metallic foreign bodies or implanted medical devices.
• • 3. Not meeting inclusion criteria as described above
• • 4. Non-fluency in English, as English is the language in the validated clinical questionnaires, and the participant must be able to understand real-time instructions from the study staff