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Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

Recruiting
10-21 years
All
Phase N/A

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Overview

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

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

Study details
    Tourette Syndrome
    Tourette Syndrome in Children
    Tourette Syndrome in Adolescence
    Tourette Syndrome
    Modifier of

NCT05628805

Children's Hospital Medical Center, Cincinnati

15 February 2024

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