Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Wolf Motor Function Test (WMFT)
研究概览
简要总结
This study will examine the combination of myoelectric computer interface (MyoCI) training with targeted memory reactivation (TMR) in chronic stroke survivors. The study aims to determine whether this training-plus-sleep combination will generalize to improve arm motor function over an extended training protocol in stroke survivors.
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)
盲法说明
Outcomes assessors and participant are blinded to groups.
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at enrollment is 21 or older
- •Hemiparesis from first ever stroke affecting arm movement at least 6 months prior to screening
- •Severe to moderate motor impairment (FMA-UE of 7-40)
- •At least some voluntary shoulder and elbow muscle activation
排除标准
- •Inability to follow instructions of the MyoCI task
- •Visual impairment (such as hemianopia) preventing full view of screen
- •Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest)
- •Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study
- •Inability to understand or follow commands in English due to aphasia or other reason
- •Diffuse or multifocal infarcts in both hemispheres
- •Substantial arm pain preventing participation for 90 minutes a day
- •Spasticity treatment (pharmacological or Botox) within last 3 months
- •Ferromagnetic implants that are MRI incompatible
研究组 & 干预措施
Sham TMR
Patients receive no TMR
干预措施: Targeted Memory Reactivation (TMR) (Other)
All phase TMR
TMR during every stage of sleep
干预措施: Targeted Memory Reactivation (TMR) (Other)
Slow-wave sleep (SWS) only TMR
TMR during slow-wave sleep only
干预措施: Targeted Memory Reactivation (TMR) (Other)
Reduced frequency TMR
TMR during only subset of sessions
干预措施: Targeted Memory Reactivation (TMR) (Other)
结局指标
主要结局
Wolf Motor Function Test (WMFT)
时间窗: change from baseline at 6 weeks
The WMFT evaluates upper extremity function on a continuous scale. It measures the time it takes to perform 15 different tasks, with a time limit of 120 s per task.
次要结局
- Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function(change from baseline at 10 weeks)
- Modified Ashworth Scale(change from baseline at 10 weeks)
- Motor Activity Log (MAL)(change from baseline at 10 weeks)
研究者
Marc Slutzky
Associate Professor
Northwestern University