A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Rehabilitation for Improved Upper Limb Function After Stroke (MicroTransponder's Vivistim System)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll. Patients will be randomized to one of two groups - a group implanted with a device that allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no implant). Patients have two baseline evaluations, one evaluation after implant but before initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS, followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of treatment. The intent is to assess safety and provide preliminary effectiveness information for VNS for upper limb functional improvement after stroke. Implanted patients may receive longer-term treatment and follow-up after the acute study.
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
- None
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
- •Major Inclusion Criteria:
- •History of unilateral supratentorial ischemic stroke that occurred at least 6 months prior
- •Age > 18 years and < 80 years
- •Right or left sided weakness of upper extremity
排除标准
- •Hemorrhagic stroke
- •Any deficits in language or attention that interferes with reasonable study participation
- •Presence of significant apraxia
- •Profound Sensory loss
- •Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including alcohol or drug abuse
研究组 & 干预措施
VNS
VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.
干预措施: Vivistim System (Device)
Rehab Only
Rehabilitation only (no implant, no VNS)
干预措施: Rehab Only (Other)
结局指标
主要结局
Safety
时间窗: 6-weeks
Assessment of adverse events and serious adverse events.
次要结局
未报告次要终点