Investigating the Effect of Responsive Neurostimulation (RNS) in Patients with Treatment-refractory Tourette's Syndrome (TR-TS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 12 months
研究概览
简要总结
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).
详细描述
Tourette's Syndrome (TS) is a neurodevelopmental disorder characterized by repetitive, involuntary movements and vocalizations known as tics. It typically manifests in childhood and may persist into adulthood. The prevalence of TS varies globally, affecting approximately 1% of the population. There is a broad spectrum of symptom severity. Treatment-refractory TS (TR-TS) refers to cases where standard therapeutic interventions, such as behavioural therapy and medications, have shown limited effectiveness. TR-TS prevalence is relatively lower but highlights the challenges in managing severe and persistent symptoms. In a comprehensive survey of diverse neuromodulation therapies, targeting specific nuclei with personalized responsive neurostimulation (RNS) has the most potential for TR-TS with apparent symptoms. However, the RNS case reports are limited and lack high-quality, evidence-based medical evidence. The stimulation targets of RNS for patients with TS include GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, and NA-ALIC. While stereoelectroencephalography (SEEG) brain mapping can help identify Individualized effective targets and stimulation parameters. So, this cohort study focuses on the effectiveness of SEEG-guided RNS on TR-TS patients. Another goal is to study the neuronal activity of the GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, and NA-ALIC, or other unreported nuclei targets, respectively. At the same time, some subjects are presented with a task involving an unexpected reward and different cognitive tasks.
Some participants will also be invited to join a related study that involves positron emission tomography (PET) scanning to determine how the stimulation changes activity in the brain. Participation in the separate PET study is optional.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 12 months
时间窗: Baseline to 12 months post-surgery
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.
次要结局
- YGTSS-Total Motor: Change in YGTSS-Total Motor at week 2, month 3, month 6, and month 12.(Baseline to week 2, month 3, month 6, and month 12)
- YGTSS-Total Phonic: Change in YGTSS-Total phonic at week 2, month 3, month 6, and month 12.(Baseline to week 2, month 3, month 6, and month 12)
- YGTSS: remission.(Baseline to week 2, month 3, month 6, and month 12)
- YGTSS: response rate.(Baseline to week 2, month 3, month 6, and month 12)
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change in Y-BOCS at week 2, month 3, month 6, and month 12.(Baseline to week 2, month 3, month 6, and month 12)
- Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in the HAMA total score.(Baseline to week 2, month 3, month 6, and month 12)
- Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 3 months, 6 months, and 12 months.(Baseline to week 2, month 3, month 6, and month 12)
- Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 3, Month 6, and Month 12.(Baseline to week 2, month 3, month 6, and month 12)
- Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in Clinical Global Impression-Severity (CGI-S) Remove(Baseline to week 2, month 3, month 6, and month 12)
- Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12.(Baseline to week 2, month 3, month 6, and month 12)
- EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 3, Month 6, and Month 12 in EQ-5D-5L.(Baseline to week 2, month 3, month 6, and month 12)
- Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12.(Baseline to week 2, month 3, month 6, and month 12)
- Safety as indicated by the number of Adverse Events: Week 2, Month 3, Month 6, and Month 12.(Baseline to week 2, month 3, month 6, and month 12)
- Change from baseline in the Verbal Fluency Test (COWAT)(1 year after neurostimulator implantation.)
- Change from baseline in the Trailmaking Test A&B(1 year after neurostimulator implantation.)
- Change in Rey-Osterrieth Complex Figure Test(1 year after neurostimulator implantation.)