Effect of RNS in Treatment-refractory Tourette's Syndrome

Sponsor
Xuanwu Hospital, Beijing
Study ID
NCT06785532
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Responsive Neurostimulation (RNS) — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Feb 5, 2025
Status verified
Jan 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment-refractory Tourette's Syndrome (TR-TS)
    Patients will undergo bilateral RNS lead implantation.

Primary Outcome Measure

Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 12 months [ Time Frame: Baseline to 12 months post-surgery ]

Central Contacts

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