Epidural Electrical Stimulation for Motor and Functional Recovery in Patients with Chronic Paralysis Due to Spinal Cord Injury: a Prospective Study Evaluating Gait Restoration, Spasticity Reduction, Pain Management, and Quality of Life Improvements Through Neuromodulation and Intensive Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Late-Stage Gait Recovery Assessed by the Fugl-Meyer Assessment for Lower Extremities
研究概览
简要总结
Spinal cord injury (SCI) is a major cause of morbidity and disability worldwide, significantly impacting patients' quality of life and functional independence. Despite advances in rehabilitation therapies, many individuals with SCI remain unable to stand or walk. Epidural electrical stimulation (EES) has emerged as a promising neuromodulation therapy to restore motor function in individuals with chronic paralysis.
This prospective clinical study aims to evaluate the efficacy and safety of EES in patients with chronic SCI who have lost the ability to stand or walk. The primary objective is to assess late-stage gait recovery following the implantation of an epidural spinal cord stimulator, using validated clinical scales such as the Fugl-Meyer Assessment - Lower Extremity (FMA-LE) and BMCA VRI.
Secondary objectives include evaluating:
The ability to stand independently (measured by the Berg Balance Scale). Improvements in walking capacity, with or without assistance. Changes in spasticity induced by EES (Modified Ashworth Scale). Reduction in pain perception (DN4, Brief Pain Inventory [BPI], Pain Disability Index [PDI]).
Improvements in neurogenic bladder and bowel dysfunction (NBSS and NBDS). Enhancements in quality of life (SCI-QOL, WHOQOL-BREF) and mood (Beck Depression Inventory [BDI]).
The study will recruit 10 adult patients (ages 18-50) with chronic, stable SCI (≥6 months post-injury) classified as ASIA A or B, with lesions between C7 and T10 and intact segmental reflexes below the injury level. Participants will undergo an intensive 3-month pre-implant rehabilitation program to maximize their baseline motor potential.
Following this period, eligible patients will receive surgical implantation of an epidural spinal cord stimulator (Medtronic Specify 5-6-5 paddle lead and Intellis pulse generator). After a 1-month post-surgical recovery period, patients will engage in a 12-month intensive rehabilitation protocol (5 supervised sessions per week), with the stimulator activated to facilitate motor recovery.
Patients will be assessed monthly through clinical evaluations and surface electromyography (EMG) to measure motor control improvements. Outcomes will be compared before and after EES implantation to determine the effectiveness of the intervention.
This study seeks to provide further evidence on the potential of epidural electrical stimulation in restoring standing and walking abilities in individuals with SCI. If successful, it could contribute to expanding treatment options for patients with chronic paralysis.
详细描述
Introduction and Rationale:
Spinal cord injury (SCI) is a major cause of long-term disability and diminished quality of life, with current rehabilitation methods often falling short of restoring independent mobility. Emerging evidence suggests that neuromodulation, particularly Epidural Electrical Stimulation (EES), can facilitate the reactivation of dormant spinal networks, thereby promoting motor recovery. Preclinical studies and initial clinical reports have demonstrated that EES can enhance neuroplasticity and improve gait function in patients with chronic paralysis. This study is designed to build on these findings by evaluating the efficacy and safety of EES in a cohort of patients with chronic, stable SCI who have lost the ability to stand or walk.
Study Objectives:
The primary objective of this prospective study is to assess late-stage gait recovery after the surgical implantation of an epidural spinal cord stimulator. Secondary objectives include improvements in standing balance, walking capacity (with or without assistance), reduction in spasticity, pain management, and enhancements in neurogenic bladder and bowel function, as well as overall quality of life and mood. This extended description outlines the technical aspects of the study design, surgical procedure, rehabilitation protocols, and neurophysiological assessments.
Study Design and Overall Methodology:
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 to 50 years.
- •Stable spinal cord injury (SCI) at least 6 months post-injury.
- •Classified as ASIA A or B with inability to stand or walk.
- •Injury located between C7 and T
- •Intact segmental reflexes below the level of injury.
- •Ability to understand and sign the informed consent form.
- •Willingness and capability to attend daily physiotherapy sessions.
- •Clinically stable overall health as determined by the investigators.
排除标准
- •Current use of electronic devices such as baclofen pumps or cardiac pacemakers.
- •Presence of comorbidities that increase surgical risk (e.g., anticoagulation therapy, cardiopulmonary issues).
- •Locomotor deformities or additional neurological disorders that may compromise evaluation.
- •Significant dysautonomia or history of stroke or myocardial infarction associated with autonomic dysreflexia.
- •MRI evidence of complete spinal cord transection, significant spinal atrophy, or significant syringomyelia.
- •Uncontrolled pain, severe spasticity, or other conditions that hinder rehabilitation participation.
- •Suspected abuse of opioids, alcohol, or other illegal substances.
- •Estimated life expectancy of less than 2 years due to severe concomitant malignant or clinical conditions.
- •Clinically significant mental health disorders.
- •Botulinum toxin injections received in the past 6 months.
- •Presence of voluntary movements during EMG testing in the lower extremities.
- •Unhealed vertebral fractures.
- •Presence of pressure ulcers.
- •Active infection.
- •Pregnancy.
研究组 & 干预措施
Epidural Electrical Stimulation + Intensive Rehabilitation Arm
Patients enrolled in this arm will undergo surgical implantation of an epidural spinal cord stimulator (Medtronic Specify 5-6-5 paddle lead and Intellis pulse generator) followed by a 12-month intensive rehabilitation program. After a one-month post-operative recovery period, electrical stimulation will be activated during five supervised physiotherapy sessions per week. The intervention combines neuromodulation with targeted motor and balance exercises to facilitate gait recovery, reduce spasticity, alleviate pain, and enhance overall quality of life. Outcomes will be monitored through clinical scales, surface electromyography, and video documentation, with patients serving as their own controls by comparing pre- and post-implantation performance.
干预措施: Epidural Electrical Stimulation (EES) using an implanted paddle lead and pulse generator combined with a 12-month intensive rehabilitation program. (Procedure)
结局指标
主要结局
Late-Stage Gait Recovery Assessed by the Fugl-Meyer Assessment for Lower Extremities
时间窗: Baseline and monthly evaluations over 12 months following epidural stimulator implantation
Evaluates lower limb motor function using the Fugl-Meyer Assessment for Lower Extremities (0-86 points; higher scores indicate better function). Baseline measurements taken before epidural stimulator implantation
Late-Stage Gait Recovery Assessed by the Brain Motor Control Assessment - Voluntary Response Index
时间窗: Baseline and monthly evaluations over 12 months following epidural stimulator implantation
Evaluates voluntary motor control and coordination using the Brain Motor Control Assessment - Voluntary Response Index (0-100 points; higher scores indicate improved control). Baseline measurements taken pre-implantation
次要结局
- Balance Assessed by the Berg Balance Scale(Baseline and monthly evaluations over 12 months post-implantation)
- Walking Ability(Baseline and monthly evaluations over 12 months post-implantation)
- Spasticity Assessed by the Modified Ashworth Scale(Baseline and monthly evaluations over 12 months post-implantation)
- Pain Perception Assessed by the Douleur Neuropathique 4 Questions(Baseline and monthly evaluations over 12 months post-implantation)
- Pain Severity Assessed by the Brief Pain Inventory(Baseline and monthly evaluations over 12 months post-implantation)
- Pain-Related Disability Assessed by the Pain Disability Index(Baseline and monthly evaluations over 12 months post-implantation)
- Neurogenic Bladder Function Assessed by the Neurogenic Bladder Symptom Score(Baseline and monthly evaluations over 12 months post-implantation)
- Neurogenic Bowel Function Assessed by the Neurogenic Bowel Dysfunction Score(Baseline and monthly evaluations over 12 months post-implantation)
- Quality of Life Assessed by the World Health Organization Quality of Life - Brief Version(Baseline and monthly evaluations over 12 months post-implantation)
- Mood Assessed by the Beck Depression Inventory(Baseline and monthly evaluations over 12 months post-implantation)