Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
United States8 participantsStarted 2022-06-20
Plain-language summary
The investigators will implant and monitor 8 research subjects with a subcortical closed-loop system for detection and suppression of tics in subjects with medically refractory debilitating Tourette Syndrome. The project will use the FDA-approved "Medtronic Percept PC" device, which is an implantable neurostimulator capable of recording neural signals. The study will target the CM nucleus of the thalamus and the aGPi in each brain hemisphere from each subject and we will connect the two leads placed in each brain hemisphere to two Percept devices.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The diagnosis of TS must be made by both a fellowship-trained movement disorders neurologist and a psychiatrist and must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for a diagnosis of TS.
* Yale Global Tic Severity Scale (YGTSS; 100) must be \>35/50 and the motor tic sub score \>15. The TS must be causing incapacitation with severe distress, self-injurious behavior, and/or quality of life disruption. OCD, Depression, and ADHD are not exclusionary provided tics are the major difficulty requiring surgical intervention.
* There are no gender criteria for this study.
* The subject's TS symptoms must be medication refractory. To meet the medication refractory criteria, subjects must have been treated by a psychiatrist or neurologist experienced in TS with therapeutic doses (doses adapted from Scahill's recommendations of at least three dopamine blocking drugs) \[either 1-4 mg/day of haloperidol, 2-8 mg/day of pimozide, risperidone (1-3 mg/day), or aripiprazole (2.5-5 mg/day)\]. There must be at a minimum7 single trial with an alpha-2 adrenergic agonist (0.1-0.3 mg/day).
* Clinically relevant depression if present must be pharmacologically treated and deemed stable (by the study psychiatrist).
* Must have been stabilized for one month on TS medication without a dose change prior to surgical intervention. If medication trials resulted in discontinuation of TS medications, the subject must be stabilized for three months off TS me…
What they're measuring
1
Yale Global Tic Severity Scale_(YGTSS) - Total Tic Score