Evaluation of Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury: an Interventional, Prospective, Monocentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 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 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 SCI from at least one-year post injury;
- •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;
- •Be 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 (i.e. metal clips, claustrophobia);
- •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;
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).
Hand-held dynamometry
时间窗: From enrollment to the end of treatment at 6 months
Quantitative assessment of maximal voluntary isometric muscle force. Measurements were performed only in muscles reaching MRC grade ≥3, corresponding to active movement against gravity. The measured outcome was the maximal force generated during isometric contraction.
IMU-based single-joint assessment
时间窗: From enrollment to the end of treatment at 6 months
Quantitative kinematic assessment of isolated lower-limb movements using wearable inertial measurement units (IMUs). The measured outcomes were the peak hip flexion angle and peak knee extension angle during stimulation-assisted single-joint movements.
Standing assessment
时间窗: From enrollment to the end of treatment at 6 months
Functional evaluation of upright standing ability. Standing performance was quantified by: * duration of maintained standing (minutes); * percentage of body weight supported through the lower limbs, measured using a stabilometric platform.
Overground walking
时间窗: From enrollment to the end of treatment at 6 months
10-Meter Walking Test (10MWT). Standardized assessment of walking speed over a 10-meter distance. The measured outcome was the time required to complete the test, from which walking speed can be derived. In motor-incomplete participants the test was performed in the OFF condition whenever feasible, whereas motor-complete participants were assessed during active stimulation. Six-minute walk test (6MWT). Standardized assessment of walking endurance. The measured outcome was the total distance walked over six minutes. Motor-incomplete participants were assessed in the OFF condition whenever feasible, whereas motor-complete participants performed the test during active stimulation.
次要结局
- Chronic pain changes (MPQ)(Before surgery and 6 months after procedure)
- Chronic pain changes (PCS)(Before surgery and 6 months after procedure)
- Longitudinal brain and spine MRI reorganization(Before surgery and 6 months after procedure)
- Spasticity changes(Before surgery, then monthly up to 6-month from surgery)
- Longitudinal neurophysiological reorganization (motor evoked potentials)(Before surgery and 6 months after procedure)
- Longitudinal neurophysiological reorganization (sensory evoked potentials)(Before surgery and 6 months after procedure)
- Longitudinal neurophysiological reorganization (electromyography)(Before surgery and 6 months after procedure)
- Chronic pain changes (ASC-12)(Before surgery and 6 months after procedure)
- Functional and neuropsychological assessment(Before surgery and 6 months after procedure)
研究者
Albano Luigi
MD, PhD, Assistant Professor of Neurosurgery
IRCCS San Raffaele