Spinal Cord Stimulation for Restoration of Arm and Hand Function in People With Subcortical Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The goal of this study is to verify whether electrical stimulation 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 which provides epidural electrical stimulation (EES) of the cervical spinal cord. Researchers will quantify the ability of EES to recruit arm and hand muscles and produce distinct kinematic movements. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neurorehabilitation programs to restore upper limb motor function in people with subcortical strokes, thereby increasing independence and quality of life.
详细描述
Specifically, researchers will 1) quantify the motor potentials in arm and hand muscles generated by single pulses of electrical stimulation of the spinal cord using FDA-cleared devices 2) characterize optimal stimulation parameter ranges to maximize induced arm and hand movement, 3) measure neural changes that could be induced by the system, 4) characterize potential clinical effects by assessing patient mobility, spasticity, and neurophysiology 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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single, ischemic or hemorrhagic stroke resulting in upper extremity hemiparesis more than 6 months prior to the time of enrollment. (Prior strokes that did not cause upper extremity motor deficits are not exclusionary.)
- •Participants must be between the ages of 21 and 70 years old.
- •Scores higher than 7 and lower than 50 on the Fugl-Meyer scale
排除标准
- •Serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments that could affect the ability to participate in study activities.
- •Pregnancy or breast feeding.
- •Receiving anticoagulant, anti-spasticity or anti-epileptic medications throughout the duration of the study.
- •Presence of any implanted medical devices.
- •Severe claustrophobia.
- •Presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities
- •Results from the Brief Symptoms Inventory (BSI-18) and additional discussions with the Principal Investigator and a study physician that deem participant inappropriate for the study.
- •Evaluation to sign consent form score <12.
结局指标
主要结局
Adverse Events
时间窗: 29 days
Study is considered successful if no serious adverse events related to the use of electrical stimulation are reported
Discomfort and Pain
时间窗: 7, 14, 21, 29 days
We will assess the relative level of discomfort and/or pain that is associated to the delivery of stimulation to the spinal cord. After each stimulation trains patients will be asked to report their perceived discomfort level using a 10 value subjective scale. Low values will be assigned to low discomfort, and high values to high discomfort.The study is considered successful if 70% of recruited subjects does not report discomfort or pain at stimulation amplitudes that are required to obtain motor responses in the muscles of the arm and hand
次要结局
- Motor Impairment(15, 29 days)
- Time to Target(7, 14, 21, 29 days)
- Single Joint Force(7, 14, 21, 29 days)
- Movement Smoothness(7, 14, 21, 29 days)
- Sensory motor integration: displacement error(7, 14, 21, 29 days)
- Cortico-spinal Tract Integrity(29 days)
- Motoneuron Firing Rates(7, 14, 21, 29 days)
- Dexterity / Function: Action Research Arm Test(7, 29 days)
- Joint Velocity(7, 14, 21, 29 days)
- Sensory motor integration: success-rate(7, 14, 21, 29 days)
- Sensorimotor Network Function(29 days)
- Spasticity(7, 15, 21, 29 days)
- Sensorimotor Network Structure Integrity(29 days)
- Spinal Circuit Excitability(7, days)
研究者
Lee Fisher, PhD
Associate Professor
University of Pittsburgh