Upregulating Corticospinal Function After Stroke Using Brain State-dependent Paired Corticomotoneuronal Stimulation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Maximum hand force output
研究概览
简要总结
After stroke, people often have difficulty using their hands. Combined brain and nerve stimulation can strengthen the neural pathways that control hand function. In this study, we will deliver combined brain and nerve stimulation during specific time windows that increase activation of neural pathways underlying hand function. We will compare the effects of combined brain and nerve stimulation during these optimal time windows to the effects of combined brain and nerve stimulation applied during random time windows on post-stroke hand function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •History of stroke > 6 months ago
- •Presence of residual upper extremity hemiparesis
- •Willingness to participate
- •Ability to provide informed consent
- •Upper extremity Fugl-Meyer score < 66
- •Mini Mental State Exam score > 24
- •Discernible and reliable motor-evoked potential (MEP) elicited following single-pulse TMS to the lesioned hemisphere
排除标准
- •History of neurological disease other than stroke
- •Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS), including: history of adverse reactions to TMS or PNS metal in head, eyes, neck, chest/trunk, or arms, including but not limited to shrapnel, surgical clips, fragments from metalworking, fragments from welding, implanted device, history of frequent and severe headaches or migraines, immediate family history of seizure or epilepsy, personal history of seizure or epilepsy, current, suspected, or planned pregnancy, current or recent (within the last 3 months) use of medications acting on the central nervous system other than selective serotonin reuptake inhibitors (SSRIs), including but not limited to antipsychotic drugs, benzodiazepines, prescription stimulants.
- •Upper extremity Fugl-Meyer score ≥ 66 (66 is the maximum on this scale)
- •Mini Mental State Exam score <= 24
- •No discernible and reliable MEP elicited following single-pulse TMS to the lesioned hemisphere
结局指标
主要结局
Maximum hand force output
时间窗: up to 1 hour after intervention
This will be measured using maximum voluntary contractions of the stroke-affected first dorsal interosseous hand muscle during pinching actions.
Maximum hand muscle activation
时间窗: up to 1 hour after intervention
This will be measured using electromyography recordings of the stroke-affected first dorsal interosseous muscle during maximum voluntary contractions during pinching actions
次要结局
- Amplitude of motor evoked potentials(up to 1 hour after intervention)
- Time to complete the 9-hole peg test(up to 1 hour after intervention)