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
About this trial
This feasibility trial is enrolling 10 participants with chronic spinal cord injury to test the effect of epidural spinal stimulation (eSS) combined with physical therapy on walking function. eSS is an invasive technique that uses an implanted electrode placed next to the spinal cord to deliver electrical stimulation aimed at modifying spinal cord function. If included, participants will undergo a 3-month pre-implant rehabilitation program, followed by surgical implantation of an epidural spinal stimulator. After 1 month for recovery and device calibration, each participant will receive electrical stimulation during five supervised physiotherapy sessions per week over 12 months. Final testing of walking function will be performed after 1 year.
Included participants
What’s involved
Type
Details
- Participants will undergo a 3-month pre-implant rehabilitation program, followed by surgical implantation of a stimulator and a 12-month post-implant rehabilitation protocol with epidural spinal stimulation (eSS). - eSS is an invasive technique that uses an implanted electrode placed next to the spinal cord to deliver electrical stimulation aimed at modifying spinal cord function. - Participants will receive eSS during 5 supervised physiotherapy sessions per week. - Final testing of walking function will be performed after 1 year.
Potential benefits
Main benefits
Standing/walking/mobility
Additional benefits
Bladder health/function
General health
Mental health and psychosocial factors
Pain
Spasticity
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more- Trial recruitment status
- Recruiting
- Trial start date
- 28 Jan 2022
- Organisation
- University of Sao Paulo General Hospital
- Trial recruitment status
- Recruiting
- Trial start date
- 28 Jan 2022
- Organisation
- University of Sao Paulo General Hospital
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more