Evaluation of Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function in Non-traumatic Spinal Cord Injury: an Interventional, Prospective, Monocentric Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Motor changes (MRC)
研究概览
简要总结
Interventional prospective longitudinal on the evaluation of spinal cord stimulation (SCS) assisted by motor rehabilitation training for restoring motor function in patients with non-traumatic spinal cord injury (SCI). The investigators will enroll ten research participants with clinically incomplete/complete SCI (patients with paraplegia or severe paraparesis) who will undergo SCS subsequently assisted by motor rehabilitation training for restoring motor function at IRCCS Ospedale San Raffaele, Milan, Italy. The main goal of the project is to evaluate the improvement in motor function generated by the combination of SCS and locomotor training. In line with recently published studies, the investigators propose that daily locomotor training in the presence of SCS with continuous stimulation parameters setting will enable the SCI individuals to stand and step independently while bearing full weight.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of NTSCI at least one year before presentation;
- •Complete or incomplete spinal cord damage (ASIA grade A, B or C) conditioning chronic neuropathic pain and motor impairment;
- •Age ≥ 18 years;
- •Indication to spinal cord stimulation surgery for chronic pain;
- •Being unable to stand or step independently;
- •No current anti-spasticity medication regimen;
- •No botox injections in the prior 3 months;
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
- •Willingness and ability to comply with scheduled visits and other trial procedures.
排除标准
- •Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study and those where MRI scanning is contraindicated;
- •Pregnancy or breastfeeding;
- •Any significant psychiatric disease;
- •Use of illicit drugs;
- •Unstable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping;
- •Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training;
- •Spinal cord involvement above the D1 segment;
- •Severe peripheral neuropathies or damage to the cauda equine.
研究组 & 干预措施
Individuals with functionally complete/incomplete non-traumatic spinal cord injury
Individuals with functionally complete/incomplete non-traumatic spinal cord injury who will undergo SCS for chronic pain
干预措施: Spinal cord stimulation surgery (device implant) and motor rehabilitation (Procedure)
结局指标
主要结局
Motor changes (MRC)
时间窗: Before surgery, then monthly up to 6-month from surgery
The Medical Research Council's (MRC) scale of muscle power will be used to evaluate motor weakness. The MRC scale of muscle strength uses a score from Grade 5 (normal) to Grade 0 (no visible contraction) to assess the power of a particular muscle group in relation to the movement of a single joint.
Motor changes (LEFS)
时间窗: Before surgery, then monthly up to 6-month from surgery
The Lower Extremity Functional Scale (LEFS) will be used by clinicians as a measure of lower extremity function. It is a questionnaire containing 20 questions about a person's ability to perform everyday tasks (minimum score 0, maximum score 80).
次要结局
- Longitudinal brain and spine MRI reorganization(Before surgery and 6 months after procedure)
- Longitudinal neurophysiological reorganization (sensory evoked potentials)(Before surgery and 6 months after procedure)
- Spasticity changes(Before surgery, then monthly up to 6-month from surgery)
- Longitudinal neurophysiological reorganization (electromyography)(Before surgery and 6 months after procedure)
- Longitudinal neurophysiological reorganization (motor evoked potentials)(Before surgery and 6 months after procedure)
- Chronic pain changes (MPQ)(Before surgery and 6 months after procedure)
- Chronic pain changes (PCS)(Before surgery and 6 months after procedure)
- Chronic pain changes (ASC-12)(Before surgery and 6 months after procedure)
研究者
Albano Luigi
MD, PhD
IRCCS San Raffaele