Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Stroke
- 发起方
- Enspire DBS Therapy, Inc.
- 入组人数
- 202
- 试验地点
- 9
- 主要终点
- Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
- 状态
- 招募中
- 最后更新
- 3个月前
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.
研究者
入排标准
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
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)