Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05628805
• Other study ID #: 2022-0747
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2022
• Est. completion date: February 17, 2025

Study information

• Verified date: February 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Molly Griffith
• Phone: 513-636-9669
• Email: molly.griffith[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Decades of Tourette Syndrome (TS) neuroimaging research has revealed abnormal cortical and subcortical motor system network, hypothesized to result from maladaptive plasticity. Repetitive transcranial magnetic stimulation ([r]TMS) is a promising technology that utilizes the concept of neuroplasticity to modulate brain circuits. TMS modulation has the distinct advantage in terms of its non-invasive nature. Furthermore, unique stimulation paradigms such as intermittent theta-burst repetitive TMS (iTBS) allows for short stimulation time (<3 min).

Using a sham-controlled protocol, the investigators propose modulating pre-SMA output using iTBS, based on our prior data of abnormal pre-SMA-mediated motor system regulation. hypothesize pre-SMA modulation results in increased pre-SMA-mediated motor inhibition. Enhancing these inhibitory measures with pre-SMA-iTBS provides the basis for improving inhibitory function in TS patients, leading to our long-term goal of neuro-stimulation to achieve clinical tic reduction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 17, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome
• Tourette Syndrome in Adolescence
• Tourette Syndrome in Children

Intervention

Device:
• iTBS
intermittent theta burst stimulation with TMS

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Tourette Association of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cortical silent period (cSP)	cSP is a biomarker of inhibitory motor physiology	On the same day, we will assess change in cSP prior to active (or sham) iTBS treatment and immediately after iTBS treatment