Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury
About this trial
This trial is enrolling 4 individuals with chronic cervical (neck area) or high thoracic (chest area) spinal cord injuries to test the effect of an implanted electrical stimulation device (Targeted Epidural Spinal Stimulation - TESS) on blood pressure stability. The research team wants to see if spinal cord stimulation can reduce the incidence and severity of orthostatic hypotension (low blood pressure) and autonomic dysreflexia (sudden high blood pressure). If included, the participant will be assessed before and after the device is implanted. After a month to customize the device to the individual, two weeks of supervised at-home use with additional scheduled laboratory TESS and assessment sessions for 25 weeks. The study will measure the long-term safety and effect of spinal cord stimulation on cardiovascular health, respiratory function, and quality of life.
Included participants
What’s involved
Type
Details
• The participant will undergo daily supervised at-home TESS sessions for 2 weeks. • Thereafter, and up to 25 weeks, participants will conduct supported at-home sessions as well as regular laboratory visits during a long-term at-home hemodynamic TESS phase. • Several clinical evaluations are planned to evaluate participants' hemodynamic and neurological status, cardiovascular functional status, respiratory function, trunk stability, and quality of life. • Final testing will be performed after 9 months.
Potential benefits
Main benefits
Standing/walking/mobility
Additional benefits
General health
Mental health and psychosocial factors
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
- Unknown
- Trial start date
- 1 Dec 2021
- Organisation
- University of Calgary
- Trial recruitment status
- Unknown
- Trial start date
- 1 Dec 2021
- Organisation
- University of Calgary
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