Enhancing Cortical Plasticity With Nerve Stimulation in Stroke Patients With Severe Motor Deficit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 主要终点
- Change in Fugl Meyer Assessment Motor Score
研究概览
简要总结
This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training, to improve hand motor function in poorly recovered stroke patients. The central hypothesis is that stroke patients with severe motor deficit receiving hand nerve stimulation and intensive task-oriented therapy will have improved motor function compared to patients receiving sham nerve stimulation and task-oriented therapy.
详细描述
Stroke is one of the most devastating and prevalent diseases, but efforts to limit the amount of tissue damaged in the acute phase have been disappointing, highlighting the need for effective therapeutic interventions after neurologic damage has occurred. Data from animal and human models have suggested that sensory input plays an important role in motor output, possibly by influencing cortical plasticity. However, in spite of the advances to date, little is known about the extent to which sensory input in the form of peripheral nerve stimulation can be successfully combined to physical training especially in poorly recovered stroke patients. This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training, to improve hand motor function in stroke patients with severe motor deficit. The central hypothesis is that stroke patients with severe motor deficit receiving hand nerve stimulation and intensive task-oriented therapy will have improved motor function compared to patients receiving sham nerve stimulation and task-oriented therapy, and the degree of this behaviorally-measured effect will correlate with the neurophysiological effect measured by transcranial magnetic stimulation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Chronic stroke patients
- •Single stroke
- •Chronic (more than 12 months after from stroke)
- •At least 21 years old, but there is no upper age range for this project.
- •Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.
排除标准
- •History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies
- •History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness
- •Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
- •Cognitive deficit severe enough to preclude informed consent
- •Positive pregnancy test or being of childbearing age and not using appropriate contraception
- •Participants with history of untreated depression.
研究组 & 干预措施
Active stimulation with motor training
2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
干预措施: S88 Dual Output Stimulator by Grass Technologies (Device)
Sham stimulation with motor training
2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
干预措施: S88 Dual Output Stimulator by Grass Technologies (Device)
结局指标
主要结局
Change in Fugl Meyer Assessment Motor Score
时间窗: baseline, post-intervention, 1-month follow-up
Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.
次要结局
- Change in Action Arm Research Test (ARAT)(baseline, post-intervention, 1-month follow-up)
- Change in Wolf Motor Function Test (WMFT)(baseline, post-intervention, 1-month follow-up)
研究者
Lumy Sawaki
Associate Professor
University of Kentucky