Effect of RNS in Treatment-refractory Tourette's Syndrome
Investigating the Effect of Responsive Neurostimulation (RNS) in Patients with Treatment-refractory Tourette's Syndrome (TR-TS)
Xuanwu Hospital, Beijing
10 participants
Feb 5, 2025
INTERVENTIONAL
Conditions
Summary
The study is to investigate the effect of personalized responsive neurostimulation (RNS) therapy guided by stereoelectroencephalography (SEEG) in patients with treatment-resistant Tourette's Syndrome (TR-TS).
Eligibility
Inclusion Criteria7
- aged 18-65;
- able to provide written informed consent;
- have a diagnosis of Tourette's syndrome according to the Statistical Manual of Mental Disorders-Fourth Edition-Text Revised (DSM-IV-TR) criteria and confirmed by the Mini-International Neuropsychiatric Interview Chinese version 5.0;
- with a YGTSS of at least 35 for at least 12 months before surgery, while YGTSS- Total Motor≥15;
- must have failed conventional medical treatment at adequate therapeutic doses of three classes of medication lasting for at least three months;
- must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful;
- have been on stable comorbid conditions without suicidal ideation for at least six months.
Exclusion Criteria11
- presence of other psychotic disorders;
- have a treatment history that includes electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), DBS, and transcranial magnetic stimulation (TMS);
- presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items);
- experience difficulty in effectively communicating with investigators;
- with a history of traumatic brain injury (TBI);
- with intracranial or cardiovascular stents;
- substance abuse within the past six months;
- unstable neurological or coagulation disorders;
- women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study;
- have been involved in other clinical studies within three months before enrollment in this study;
- any conditions considered by the study group.
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Interventions
The RNS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.
Locations(1)
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NCT06785532