ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
About this trial
This trial is enrolling 60 participants with chronic spinal cord injury to test the effect of epidural spinal stimulation on blood pressure. Epidural spinal stimulation 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 surgical implantation of the ARC-IM System and will be randomly assigned to undergo therapy sessions with either active or sham stimulation, followed by active stimulation for all participants after 3 months. Final testing of blood pressure stability will be performed after 6 months.
Included participants
Traumatic
What’s involved
Type
Details
- Participants will undergo surgical implantation of the ARC-IM System, an epidural stimulator, and will be randomly assigned to undergo therapy sessions with either active or sham stimulation. - Epidural spinal stimulation (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. - After 3 months, all participants will receive active stimulation. - Final testing of blood pressure stability will be performed after 6 months.
Potential benefits
Main benefits
General health
Additional benefits
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 soon
- Trial start date
- 1 Sep 2025
- Organisation
- ONWARD Medical, Inc.
- Trial recruitment status
- Recruiting soon
- Trial start date
- 1 Sep 2025
- Organisation
- ONWARD Medical, Inc.
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