Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)
About this trial
This is a trial to test the safety and effectiveness of spinal cord stimulation on pain and muscle function after spinal cord injury. If included, participants will undergo surgery for implantation of a stimulation device next to the spinal cord (epidural). Participants will then receive 9 months of conventional medical and rehabilitation management with either: 1) spinal cord stimulation turned on; or 2) spinal cord stimulation turned off (no stimulation). Participants will not know which group they are in until the end of the 9 months. At the end of the 9 months, participants who were in the spinal cord stimulation off group (no stimulation) can have their spinal cord stimulator turned on.
Included participants
Traumatic
What’s involved
Type
Details
Participants will undergo surgery for implantation of the stimulation device next to the spinal cord. Participants will receive 9 months of conventional medical and rehabilitation management with either: 1) spinal cord stimulation turned on; or 2) spinal cord stimulation turned off (no stimulation). At the of the 9 months, the sham group will also be able to turn on SCS. Final testing will be performed after 9 months.
Potential benefits
Main benefits
Pain
Additional benefits
Arm/hand function
Bladder health/function
General health
Mental health and psychosocial factors
Sensory function
Spasticity
Standing/walking/mobility
Mechanism of action
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
- 30 Dec 2021
- Organisation
- Duke University
- Trial recruitment status
- Recruiting
- Trial start date
- 30 Dec 2021
- Organisation
- Duke University
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