Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome (NCT05628805) | Clinical Trial Compass
CompletedNot Applicable
Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome
United States16 participantsStarted 2022-11-01
Plain-language 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.
Who can participate
Age range10 Years – 21 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. Presence of metallic foreign bodies or implanted medical devices.
✕. Not meeting inclusion criteria as described above
What they're measuring
1
change in cortical silent period (cSP)
Timeframe: On the same day, we will assess change in cSP prior to active (or sham) iTBS treatment and immediately after iTBS treatment
Trial details
NCT IDNCT05628805
SponsorChildren's Hospital Medical Center, Cincinnati
✕. 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