Epidural Electrical Stimulation to Restore Standing and Walking in Patients With Chronic P
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 p
| Condition(s) | Spinal Cord Injuries (SCI), Paralysis, Lower Limbs |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 V |
| Who can participate | 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 dy |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Lead sponsor | University of Sao Paulo General Hospital |
| Locations | São Paulo, São Paulo, Brazil |
| Start date | 2022-01-28 |
| NCT ID | NCT06847295 |
| Official listing | https://clinicaltrials.gov/study/NCT06847295 |