Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA)
研究概览
简要总结
This study aims to verify whether epidural electrical stimulation (EES) of the cervical spinal cord can activate muscles of the upper limbs in people with hemiplegia following a stroke.
详细描述
The purpose of this study is to verify whether epidural electrical stimulation (EES) of the cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia following stroke. Participants will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, Participants will undergo a structured physical rehabilitation program and electrical stimulation. Researchers will quantify the motor potentials in the arm and hand muscles generated by EES of the cervical spinal cord, tune optimal stimulation parameters to induced arm and hand movement, and assess participant motor function of the upper limb with standard clinical tests and simple motor tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 20 and 70 years of age
- •First-ever clinical manifest stroke
- •Right or left hemiparesis
- •Scores higher than 7 and lower than 45 on the Fugl-Meyer scale.
- •Expected will undergo spinal cord stimulation surgery.
- •Able to comply with procedures and follow up.
- •Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities.
排除标准
- •Pregnancy or breast feeding.
- •Have Major depressive disorder.
- •Had a mental illness within one year or been treated in the past.
- •Have significant cognitive impairment (MMSE<24) or serious disease that could affect the ability to participate in study activities.
- •Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention.
- •Receiving anticoagulant, anti-spasticity or anti-epileptic medications prior to or throughout the duration of the study.
- •Unable to read and/or comprehend the consent form.
- •Have concerns about this trial and do not sign consent.
- •Presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities.
结局指标
主要结局
Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA)
时间窗: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is main assesses motor functioning and sensation in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and plan and assess treatment. The upper extremity motor function score ranges from 0 to 66.
Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)
时间窗: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. The score ranges from 0 to 57, with a higher value indicating better function.
次要结局
- Change in spasticity as measured by the Modified Ashworth Scale (MAS)(Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation)
- Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)(Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation)