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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

RecruitingNAAges 18 Years - 50 YearsAllUniversity of Sao Paulo General Hospital
NCT06847295 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Epidural Electrical Stimulation (EES) using an implanted paddle lead and pulse generator combined with a 12-month intensive rehabilitation program.
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Where

1 site
University of São Paulo General Hospital
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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