tDCS Over the Supplemental Motor Area for the Treatment of Tourette Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS)
研究概览
简要总结
Double-blind randomized, sham-controlled clinical trial of 1 mA bilateral supplementary motor area in adolescents/adults with Tourette syndrome (TS). The primary objectives are to assess and quantify the safety and efficacy on tic severity of 5 inhibitory sessions of active vs. sham tDCS sessions during active tic suppression, and to explore the differences in brain functional activity before and after 5 sessions of active or sham cathodal tDCS in adolescents and adults with TS. Secondary objectives include the assessment of the severity of comorbidities after 5 inhibitory tDCS sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who meet Diagnostic and Statistical Manual of Mental Disorders criteria for TS (APA, DSM V).
- •16 years of age or older.
- •A "moderately ill" or worse score on the Clinical Global Impression Severity scale (CGI-S).
- •A total motor tic or vocal tic severity score greater or equal to 15/25 on the Yale Global Tic Severity Scale (YGTSS) or a combined score greater than 22/
- •Participants should be either un-medicated or on stable medication treatment for tics for the previous 3 months. If receiving botulinum toxin treatment, their enrolment should be at least 16 weeks after the last treatment session.
- •Psychiatric comorbidities should be clinically stable; treatment has not changed in the last 3 months.
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria:
- •Have a metal object/implant in their brain, skull, scalp, or neck.
- •Have an implantable device (e.g., cardiac pacemaker).
- •Have a diagnosis of epilepsy or cardiac disease.
- •Have a history of traumatic brain injury, learning disability or dyslexia.
- •Have a severe impediment in vision or hearing.
结局指标
主要结局
Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS)
时间窗: 1 week after end of intervention
The Yale Global Tic Severity Scale is the most extensively deployed scale worldwide for measuring tic severity. It requires an experienced clinician using all available information to rate motor and phonic tic severity during the previous week. Five dimensions (number, frequency, intensity, complexity, and interference) of motor and phonic tics are rated separately on a six point Likert-type scale (zero-five), with each point anchored to descriptive statements and relevant examples. The global score has a zero-one hundred range, composed by severity and overall impairment scores, each of which having a zero-fifty range. Higher values indicate worse outcome.
次要结局
- Adverse effects(Immediately after and 1 week after last tDCS session)
- Tourette Syndrome Clinical Global Impression (TS-CGI)(Immediately after and 1 week after last tDCS session)
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS)(Immediately after and 1 week after last tDCS session)
- Tic inhibition potential on the Modified Video-Based Tic Rating Scale (MVBTRS)(Immediately after and 1 week after last tDCS session)
- Individualized-Premonitory Urge for Tics Scale (iPUTS)(Immediately after and 1 week after last tDCS session)