Effect of RNS in Treatment-refractory Tourette's Syndrome
ConditionTourette Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXuanwu Hospital, Beijing
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Responsive Neurostimulation (RNS)
DeviceThe 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Treatment-refractory Tourette's Syndrome (TR-TS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 12 months
The YGTSS is a 10-item semi-structured clinician-rating instrument that evaluates motor and phonic symptoms' number, frequency, intensity, complexity, and interference. The items about the tic ratings are scored on two subscales: motor tics and phonic tics. Behaviors are rated on a 6-point scale. The Total Tic Severity Score ranges from 0-50, with a higher score indicating a higher severity of symptoms.
Time frame
Baseline to 12 months post-surgerySecondary outcomes
1
YGTSS-Total Motor: Change in YGTSS-Total Motor at week 2, month 3, month 6, and month 12.
The YGTSS motor tics are rated on a 6-point scale. The score ranges from 0-25, with a higher score indicating a higher severity of symptoms.
Time frame
Baseline to week 2, month 3, month 6, and month 122
YGTSS-Total Phonic: Change in YGTSS-Total phonic at week 2, month 3, month 6, and month 12.
The YGTSS phonic tics are rated on a 6-point scale. The score ranges from 0-25, with a higher score indicating a higher severity of symptoms.
Time frame
Baseline to week 2, month 3, month 6, and month 123
YGTSS: remission.
Remission (defined as YGTSS total score ≤14) at Week 2, Month 3, Month 6, and Month 12.
Time frame
Baseline to week 2, month 3, month 6, and month 124
YGTSS: response rate.
Response is a ≥35% reduction in YGTSS total score from baseline to Week 2, Month 3, Month 6, and Month 12.
Time frame
Baseline to week 2, month 3, month 6, and month 12Sponsors and contacts
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Source ClinicalTrials.gov