Restoration of Standing and Walking With ISMS in Humans
About this trial
This trial is recruiting individuals with chronic complete paraplegia to test the usage of electrical stimulation in the spinal cord to potentially restore control of standing or walking. The study aims to extend by two hours a routine spinal surgery (used to correct a deformity or stabilize the lower thoracic spine) in order to evaluate an IntraSpinal Micro-Stimulation (ISMS) device to map and stimulate part of the spinal cord (T9-12). The device will also measure the effect on the leg muscles used for standing or walking, across the hips, knees and ankles. If selected, participants will receive standard surgery with an extension of 2 hours to conduct the ISMS study. Movement assessment and MRI will be done before and after the intervention.
Included participants
Traumatic
Non-traumatic
What’s involved
Type
Details
The participant will undergo the planned thoracic surgery with an extension to conduct the study using the ISMS device. Before and after the surgery, the participant will do a gait assessment and an MRI scan. The follow-up assessment will be done 1, 3 and 6 month post-surgery.
Potential benefits
Main benefits
Standing/walking/mobility
Additional benefits
General health
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
- Ended
- Trial start date
- 1 Jan 2015
- Organisation
- Vanderbilt University Medical Center
- Trial recruitment status
- Ended
- Trial start date
- 1 Jan 2015
- Organisation
- Vanderbilt University Medical Center
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