Spinal Cord Stimulation for Reanimation After Nervous System Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Nerve transfer recipient muscle strength
研究概览
简要总结
Restoring upper extremity function in patients with cervical spinal cord injury is extremely important for patients' independence and quality of life.
At present, there are limited options for hand or arm reanimation in this patient population. Nerve transfer is one such option that can partially restore the natural movement of hand or arm function in select patients.
The investigators are interested in understanding whether recovery of hand or arm motor function after nerve transfer can be augmented by cervical epidural spinal cord stimulation.
详细描述
The study will enroll up to 20 participants in a single arm prospective clinical study. Potential participants will have already had a nerve transfer surgery more than 6 months prior to enrollment and will have also completed post-nerve transfer physical /occupational neurorehabilitation.
At baseline, upper extremity muscle strength, muscle force and nerve health with needle electromyography and neuroimaging will be tested.
Patients will undergo percutaneous (temporary) spinal cord stimulator leads placement in the cervical supralesional spine region.
Week 0-4: Weekly testing of motor function and muscle contraction force with the stimulation turned on versus turned off will be performed. Stimulation parameters for each target upper extremity muscle will also be documented.
Temporary leads will be removed after approximately 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤65
- •Provides informed consent
- •History of upper extremity nerve transfer > 6 months prior to enrollment
- •Completion of standard post-nerve transfer occupational therapy
- •Baseline upper extremity strength of < 5/5 grade with the MRC
- •Scheduled to undergo a cervical spinal cord stimulation procedure for chronic pain refractory to first line therapy
- •Willing and able to adhere to the study protocol
排除标准
- •Central nervous system (CNS) malignancy
- •A contraindication to the SCS procedure
- •Diagnosis that precludes the patient from full participation in the protocol
- •A functional implanted device (pacemaker, vagus nerve device, baclofen pump)
- •Botulinum toxin injection in upper extremity muscles < 6 months prior to enrollment
- •For female participants, current/planned pregnancy (females of childbearing age will be asked to take a pregnancy test on the day of the intervention)
- •Other factors that prevent participation in the opinion of the surgeon-principal investigator
结局指标
主要结局
Nerve transfer recipient muscle strength
时间窗: 0-6 weeks
Change in Medical Research Council (MRC) grade of recipient nerve transfer muscle group with spinal cord stimulation activated. MRC ranges from 0 (no visible muscle contraction) to 5 (normal muscle strength against full resistance). A larger number represents a better outcome.
次要结局
- Nerve transfer recipient muscle force(0-6 weeks)
- Frequency of percutaneous stimulation(0-4 weeks)
- Neck and upper extremity pain(0-6 weeks)
- Amplitude of percutaneous stimulation(0-4 weeks)
- Pulse width of percutaneous stimulation(0-4 weeks)
研究者
Yi Lu, MD PhD
Director of Neurosurgical Trauma, Associate Professor of Neurosurgery
Brigham and Women's Hospital