Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

NCT05628805 | Completed FDA Device

• 1 other identifier: 2022-0747
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

iTBS

EXPERIMENTAL

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

Sham iTBS

SHAM COMPARATOR

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

Interventions

iTBS DEVICE

intermittent theta burst stimulation with TMS

Sham iTBS; iTBS

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants of any sex, race, or ethnicity meeting all criteria listed below will be included in the study:
• Aged 10-21 years
• Fluent in English
• DSM-5 diagnosis of TS, confirmed by the clinical team
• 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.
• 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.

You may not qualify if:

• Presence of metallic foreign bodies or implanted medical devices.
• 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

Sponsors & Collaborators

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

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Modifier, X-Linked, for Neurofunctional Defects

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 29, 2022
• Study Start: November 1, 2022
• Primary Completion: February 16, 2026
• Study Completion: February 16, 2026
• Last Updated: March 18, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)