Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment
研究概览
简要总结
Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.
详细描述
This study will look at the differences in improvement of hand and arm function when nerve stimulation is applied at different times in relation to motor training. The nerve stimulation, called peripheral nerve stimulation (PNS), is non-invasive and painless. Subjects in the study may receive strong or mild PNS. Subjects will also vary by whether PNS is delivered for 2 hours before the 2 hours of motor training, or during the 2 hours of motor training. Which level of stimulation and its timing will be determined randomly for each subject.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have severe upper extremity motor deficit after a single stroke
- •Stroke onset at least 12 months ago
排除标准
- •Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment
- •Untreated depression
- •History of multiple strokes
- •History of seizure
- •History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
- •Positive pregnancy test or being of childbearing age and not using appropriate contraception
- •Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain
- •Cardiac or neural pacemakers or implanted medication pumps
- •Receptive aphasia
研究组 & 干预措施
Active PNS during training
Individuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm.
干预措施: Intensive upper extremity motor training (Behavioral)
Active PNS during training
Individuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm.
干预措施: Peripheral nerve stimulation (PNS) (Device)
Active PNS before training
Individuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm.
干预措施: Peripheral nerve stimulation (PNS) (Device)
Active PNS before training
Individuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm.
干预措施: Intensive upper extremity motor training (Behavioral)
Sham PNS during training
Individuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm.
干预措施: Peripheral nerve stimulation (PNS) (Device)
Sham PNS during training
Individuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm.
干预措施: Intensive upper extremity motor training (Behavioral)
结局指标
主要结局
Fugl-Meyer Assessment
时间窗: Baseline, Immediately post-intervention
This is a quantitative measure of motor recovery, coordination, and speed.
次要结局
- Stroke Impact Scale(Baseline, Immediately post-intervention)
- Cortical motor map volume(Baseline, Immediately post-intervention)
- Action Research Arm Test(Baseline, Immediately post-intervention)
研究者
Lumy Sawaki
Associate Professor
University of Kentucky