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
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
University of Sao Paulo General Hospital
10 participants
Jan 28, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 T10.
- 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.
Exclusion Criteria15
- 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.
Interventions
The intervention consists of surgical implantation of an epidural electrical stimulator using a paddle lead (Medtronic Specify 5-6-5) placed in the lumbar epidural space and a subcutaneously implanted pulse generator (Medtronic Intellis). After a one-month recovery and device calibration period, the stimulator is activated during a 12-month intensive rehabilitation program. Patients receive electrical stimulation during five supervised physiotherapy sessions per week. Stimulation parameters-including pulse width, frequency, and amplitude-are individually optimized based on intraoperative neurophysiological monitoring and ongoing clinical assessments, with the goal of enhancing gait recovery, reducing spasticity, and improving overall motor function and quality of life.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06847295