Epidural Electrical Stimulation to Restore Standing and Walking in Patients With Chronic Paralysis Due to Spinal Cord Injury: A Study on Motor Recovery, Spasticity Reduction, and Quality of Life Improvement Through Neuromodulation and Intensive Rehabilitation
brief summary
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.
detailed description
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:
This is a single-arm, prospective clinical study designed to follow each patient as their own control by comparing pre-operative and post-operative functional status. The study will enroll 10 adult patients with chronic SCI (≥6 months post-injury) classified as ASIA A or B, with lesions located between C7 and T10 and preserved segmental reflexes below the level of injury. Prior to surgical intervention, participants will undergo a 3-month intensive rehabilitation program aimed at maximizing their baseline motor function. This phase includes five supervised physiotherapy sessions per week, during which comprehensive clinical assessments, video documentation, and surface electromyography (EMG) recordings are collected.
Surgical Procedure and Device Implantation:
Following the pre-operative rehabilitation phase, patients will undergo a surgical procedure for the implantation of an epidural spinal cord stimulator. The procedure is performed in a sterile operating room at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo. Key technical details of the procedure include:
official title
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