Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome - A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Yale Global Tic Severity Scale (YGTSS)
研究概览
简要总结
The motor tics associated with Tourette's syndrome may be reduced with deep brain stimulation of the anterior globus pallidus. The best area within this brain region and the best stimulation device settings are currently unknown. This is a study in which deep versus superficial electrode contact positions and two different amplitudes of stimulation are compared under scientific conditions. The hypothesis is that one contact position/stimulation amplitude combination will provide a better outcome than the others. Each study participant receives each of four different anatomical position/stimulation amplitude setting combinations over a 12 month period in randomized order followed by a 6-month period of trial-and-error device programming to optimize control of motor tics. Motor tics, potential side effects, daily functioning and quality of life are assessed at the end of each trial stimulation period. At the end of the study, the study participant continues to have long-term deep brain stimulation treatment with whatever settings provide the most relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14 to 60 years
- •Patient Group with Tourette's syndrome - severe and resistant to medical treatment including antipsychotic medication
排除标准
- •Surgical contraindications to deep brain stimulation surgery
- •Major Depressive Episode within the previous 6 months
- •Schizophrenia or other psychotic disorder
- •Personality disorder impairing ability to reliably comply with study protocol
- •Significant cognitive impairment
结局指标
主要结局
Yale Global Tic Severity Scale (YGTSS)
时间窗: 18 months
At the end of the 6 month non-randomized empirical stimulation period.
次要结局
- Modified Rush Video Rating Scale and tic counts(18 months)
- Tourette's syndrome symptom list(18 months)
- Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)(18 months)
- Short Form 36(18 months)
- Montreal Cognitive Assessment (MoCA)(18 months)
- Adverse effects list(12 months)
研究者
Professor Christopher Lind
Consultant Neurosurgeon
The University of Western Australia