Effect of RNS in Treatment-refractory Tourette's Syndrome

Launched by XUANWU HOSPITAL, BEIJING · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for adults with Tourette's Syndrome who have not found relief from other therapies. The study is looking at a method called responsive neurostimulation (RNS), which uses a device to help control symptoms by sending targeted electrical signals to the brain. Researchers want to see how well this treatment works for people whose Tourette's has not improved with standard medications.

To participate, individuals must be between 18 and 65 years old and have been diagnosed with Tourette's Syndrome. They should have had significant symptoms for at least a year and have tried multiple medications without success. Participants will need to be able to understand and agree to take part in the study. If eligible, they can expect to receive personalized treatment and be closely monitored throughout the trial. It’s important to note that certain conditions, like a history of severe mental health issues or recent substance abuse, may prevent someone from joining, ensuring the safety of all participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. aged 18-65;
• • 2. able to provide written informed consent;
• • 3. 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;
• • 4. with a YGTSS of at least 35 for at least 12 months before surgery, while YGTSS- Total Motor≥15;
• • 5. must have failed conventional medical treatment at adequate therapeutic doses of three classes of medication lasting for at least three months;
• • 6. must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful;
• • 7. have been on stable comorbid conditions without suicidal ideation for at least six months.
• Exclusion Criteria:
• • 1. presence of other psychotic disorders;
• • 2. 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);
• • 3. presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items);
• • 4. experience difficulty in effectively communicating with investigators;
• • 5. with a history of traumatic brain injury (TBI);
• • 6. with intracranial or cardiovascular stents;
• • 7. substance abuse within the past six months;
• • 8. unstable neurological or coagulation disorders;
• • 9. women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study;
• • 10. have been involved in other clinical studies within three months before enrollment in this study;
• • 11. any conditions considered by the study group.