Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

Last updated: February 5, 2024
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting

Phase

1

Condition

Tic Disorders

Autism

Treatment

iTBS

Clinical Study ID

NCT05628805
2022-0747
  • Ages 10-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Participants of any sex, race, or ethnicity meeting all criteria listed below will beincluded 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 informedconsent/assent and provide a spontaneous narrative description of the key elements ofthe study.
  5. Clinical stability: determined by a physician, no switch of psychotropic medicationsor increase in dosage in the last 14 days from TMS treatment start; no change in othertherapeutic interventions in last 14 days from TMS treatment start.

Exclusion

Exclusion Criteria:

  1. Any neurodevelopmental, psychiatric condition other than TS, ADHD, or OCD, or mildanxiety based on review of K-SADS. Note - if an exclusionary psychiatric diagnosis issuspected based on K-SADS, the research physician will follow up with the parent andreferral 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 clinicalquestionnaires, and the participant must be able to understand real-time instructionsfrom the study staff

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: iTBS
Phase: 1
Study Start date:
November 01, 2022
Estimated Completion Date:
February 17, 2025

Connect with a study center

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

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