Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05628805
• Collaborator: Tourette Association of America (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tourette Syndrome; Tourette Syndrome in Children; Tourette Syndrome in Adolescence; Tourette Syndrome, Modifier of	Device: iTBS	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome
• Actual Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iTBS Each participant will have two separate study days in the TMS lab. On one day, the participant will receive active pre-SMA iTBS. On the other day, the patricipant will receive sham pre-SMA iTBS. The order that active versus sham is given will be randomized and the participant will be blinded. After each iTBS session, blinding assessment will be performed. To avoid contamination of results, a minimum of 5 days between study days will be required.	Device: iTBS; intermittent theta burst stimulation with TMS
Sham Comparator: Sham iTBS Each participant will have two separate study days in the TMS lab. On one day, the participant will receive active pre-SMA iTBS. On the other day, the patricipant will receive sham pre-SMA iTBS. The order that active versus sham is given will be randomized and the participant will be blinded. After each iTBS session, blinding assessment will be performed. To avoid contamination of results, a minimum of 5 days between study days will be required.	Device: iTBS; intermittent theta burst stimulation with TMS

Outcome Measures

Primary Outcome Measures

1. change in cortical silent period (cSP) [On the same day, we will assess change in cSP prior to active (or sham) iTBS treatment and immediately after iTBS treatment]

   cSP is a biomarker of inhibitory motor physiology

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati
• Tourette Association of America

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Travis Larsh, Assistant Professor, Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT05628805
• Other Study ID Numbers: 2022-0747
• First Posted: Nov 29, 2022
• Last Update Posted: Nov 29, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Tourette Syndrome; Syndrome

Study Results

No Results Posted as of Nov 29, 2022