Epidural electrical stimulation to help patients with chronic paralysis stand and walk again
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
This study is testing if a special electrical device can help people with chronic spinal cord injuries stand and walk again after a year of rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06847295 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the efficacy and safety of epidural electrical stimulation (EES) in patients with chronic spinal cord injuries who have lost the ability to stand or walk. The study involves the surgical implantation of an epidural spinal cord stimulator, followed by a 12-month intensive rehabilitation program. Primary outcomes include assessing gait recovery and secondary outcomes focus on improvements in balance, walking capacity, spasticity reduction, and overall quality of life. The study aims to leverage neuromodulation to enhance neuroplasticity and restore motor function in affected individuals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 50 with stable spinal cord injuries classified as ASIA A or B, who are unable to stand or walk.
Not a fit: Patients with significant comorbidities, current use of electronic devices that may interfere with the study, or those with complete spinal cord transection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients with chronic paralysis due to spinal cord injuries.
How similar studies have performed: Preliminary studies have shown promise for similar neuromodulation approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
São Paulo, São Paulo
- University of São Paulo General Hospital — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Guilherme Alves Lepski, MD, PhD — University of Sao Paulo
- Study coordinator: Matheus Moreli Porceban, MD, PhD student
- Email: matheus.porceban@hc.fm.usp.br
- Phone: +5511999157497
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.