Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury

Status: Unknown
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to stimulate the circuits in the spinal cord that are directly responsible for hemodynamic control to restore hemodynamic stability in participants with chronic cervical or high-thoracic spinal cord injury. The ultimate objective of this study is to provide preliminary safety and efficacy measures on the ability of the hemodynamic Targeted Epidural Spinal Stimulation (TESS) to ensure the long-term management of hemodynamic instability and reduce the incidence and severity of orthostatic hypotension and autonomic dysreflexia episodes in individuals with chronic cervical or high-thoracic spinal cord injury. In addition, the long-term safety and efficacy of TESS on cardiovascular health, respiratory function, and quality of life in participants with chronic spinal cord injury will be evaluated.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age 18 to 70 years old

• Able to undergo the informed consent/assent process

• Radiologically confirmed spinal cord injury

• Spinal cord injury between C3 and T6

• Classified with American Spinal Injury Association Impairment Scale (AIS) A or B Spinal cord injury

• Stable medical, physical and psychological condition as considered by Investigators

• Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation

• Confirmed orthostatic hypotension and autonomic dysreflexia

• Willing to attend all scheduled appointments

Locations
Other Locations
Canada
University of Calgary
RECRUITING
Calgary
Contact Information
Primary
Study Coordinator
restorenetwork@ucalgary.ca
4032107438
Time Frame
Start Date: 2021-12
Completion Date: 2023-12
Participants
Target number of participants: 8
Treatments
Experimental: Targeted Epidural Spinal Stimulation
Participants will undergo surgery to implant devices that will be used for Targeted Epidural Spinal Stimulation (TESS).
Sponsors
Leads: Aaron Phillips

This content was sourced from clinicaltrials.gov