Cyclic Versus Continuous Deep Brain Stimulation in Essential Tremor
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Fahn-Tolosa-Marin Tremor Rating Scale - total score difference
研究概览
简要总结
The aim of the study is to prove the efficacy and safety of cyclical deep brain stimulation (DBS) in patients with essential tremor, and demonstrate non-inferiority of cyclical DBS on tremor control when compared to continuous stimulation.
详细描述
This study is a prospective, randomized, double-blind cross-over trials. Patients will be randomized into two groups in a cross-over fashion to have either continuous or cyclical stimulation for a total of three months. Following this, the trial will be unblinded and open-label follow up will continue for another nine months. Device use as per standard practice continues after the end of the trial.
If the hypothesis is proven correct, this will provide proof of concept that cyclical stimulation for the treatment of essential tremor results in improved battery life, reduced number of operations for battery changes, reduction in stimulation side-effects and enhancing quality of life.
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)
盲法说明
This study adopts a blind design. Only the programmer is aware of the randomisation details and the parameters will be kept separately in order to keep others blind about the intervention. Unblinding of the study will occur at the 3rd month of the study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is at least 18 years of age
- •Participant has confirmed diagnosis of medically-refractory essential tremor
- •Participant meets criteria for implantation of DBS system
- •Participant understands the study requirements and treatments procedures and provides informed consent before any study-specific tests or procedures are performed
排除标准
- •Participant meets any contraindications for implantation of DBS system
- •Participant is undergoing or has had previous thalamic stimulation either in a research trial or with a permanent implant
- •Participant is unwilling or unable to comply with all study required follow-up evaluations
结局指标
主要结局
Fahn-Tolosa-Marin Tremor Rating Scale - total score difference
时间窗: 6 months compared to baseline
Change in Fahn-Tolosa-Marin tremor rating scale at 6 months compared to baseline. Minimum score is 0 and maximum score is 84. Higher scores indicate worse tremor control
次要结局
- EuroQol five dimensions questionnaire (EQ-5D) difference(6 months post activation compared to baseline)
- Clinical Global Impression of Change (CGI) difference(6 months post activation compared to baseline)
- Quality of Life in Essential Tremor (QUEST) questionnaire difference(6 months post activation compared to baseline)
- Satisfaction with Treatment (SWT) questionnaire difference(6 months post activation compared to baseline)
- Implantable Pulse Generator (IPG) power consumption and longevity(6 months compared to baseline)
- Beck's Depression Index questionnaire difference(6 months post activation compared to baseline)