Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 16
- 主要终点
- Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
研究概览
简要总结
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
详细描述
The RESTORE Stroke Study combines two phases of study under one protocol (pilot/pivotal). The first phase has a sample size of 40 subjects. The second phase has an estimated sample size of 162 subjects which may be adjusted based on analysis of the first phase.
Each subject will be implanted with the DBS system, undergo DBS program optimization, and be randomized to test treatment (Tt) or active-control treatment (Ct). After randomization, all subjects will participate in a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, subjects assigned to active-control treatment (Ct) will cross over to receive test treatment (Tt) and participate in a second five-month therapy program.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, Care Providers (Therapists), Investigators, and Outcome Assessors do not know to which group the participants are randomized.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.
排除标准
- •Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
- •Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus
研究组 & 干预措施
DBS+Rehab
Active-DBS combined with motor rehabilitation
干预措施: Deep Brain Stimulation (Device)
Rehab
Control-DBS combined with motor rehabilitation
干预措施: Rehabilitation (Other)
结局指标
主要结局
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
时间窗: Week-12 to Week-32
The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct).
次要结局
- Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)(Week-12 to Week-32)