Autonomic Effects of Stimulation in SCI

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Dec 15, 2022

Keywords

ClinConnect Summary

This clinical trial, called "Autonomic Effects of Stimulation in SCI," is looking at how a special device that stimulates the spinal cord can help people with spinal cord injuries (SCI). The main goals are to see if this stimulation can help increase blood pressure, improve how long someone can exercise using an arm bike, and help the body recover heart rate more quickly after exercise. The researchers are also interested in finding out if this device can help control body temperature in cooler environments.

To participate in this study, individuals must have had a spinal cord injury for over a year and be unable to walk. They should have a specific type of injury (between the C3 and T1 vertebrae) and be on stable medication for at least 30 days. Participants need to be able to attend seven study visits over the next two months. People with certain health issues, such as a history of seizures or significant heart problems, may not be eligible. If you or someone you know meets these criteria and is interested in helping advance our understanding of spinal cord injury treatments, this study could be a great opportunity!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • injury more than 1 year ago, non-ambulatory
• • level of lesion C3-T6, AIS A, B, or C
• • stable prescription medication regimen for at least 30 days
• • must be able to commit to study requirements of 7 visits within a 60-day period
• Exclusion Criteria:
• • extensive history of seizures
• • ventilator dependence or patent tracheostomy site
• • history of neurologic disorder other than SCI
• • history of moderate or severe head trauma
• • contraindications to spine stimulation
• • significant cardiovascular disease
• • active psychological disorder
• • recent history (within 3 months) of substance abuse
• • open skin lesions over spine at levels targeted for stimulation (L1/L2) and pregnancy