Using theta burst stimulation to improve motor function in Tourette Syndrome

Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

This study is testing whether a new brain stimulation technique can help young people with Tourette Syndrome improve their motor skills.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 10 Years to 21 Years
• Sex: All
• Sponsor: Children's Hospital Medical Center, Cincinnati (Academic / other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT05628805 on ClinicalTrials.gov

What this trial studies

This study aims to explore the effects of intermittent theta-burst stimulation (iTBS) on the motor system in patients with Tourette Syndrome (TS). By utilizing a sham-controlled protocol, the researchers will modulate the output of the pre-supplementary motor area (pre-SMA) to enhance inhibitory control in the motor system. The study focuses on participants aged 10-21 years who have a confirmed diagnosis of TS and are clinically stable. The non-invasive nature of TMS allows for a quick stimulation process, potentially leading to improved motor function in TS patients.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 10-21 years with a DSM-5 diagnosis of Tourette Syndrome who are clinically stable.

Not a fit: Patients with additional neurodevelopmental or psychiatric conditions beyond Tourette Syndrome, ADHD, or mild anxiety may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance motor inhibition in patients with Tourette Syndrome, improving their quality of life.

How similar studies have performed: While the use of TMS in treating Tourette Syndrome is a relatively novel approach, similar studies have shown promise in modulating brain circuits for other neurological conditions.

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

Where this trial is running

Cincinnati, Ohio

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Molly Griffith

Conditions Tourette Syndrome; Tourette Syndrome in Children; Tourette Syndrome in Adolescence; Tourette Syndrome, Modifier of