Transcutaneous spinal cord stimulation and its impact on cardiovascular autonomic regulation after spinal cord injury.
Ryan Solinsky, Kathryn Burns, Christopher Tuthill...
https://pubmed.ncbi.nlm.nih.gov/37947438Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID07210411
Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
Led by Mayo Clinic · Updated on 2026-05-28
80
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the body controls changes in blood pressure and how spinal cord stimulation affects these changes along with immune and cardiovascular functions in people with spinal cord injury. The study includes individuals with spinal cord injuries at neurological levels C6 to T8 and uninjured control participants to understand a range of autonomic dysfunctions after injury. Participants will be grouped into controls without spinal cord injury, those with spinal cord injury receiving transcutaneous stimulation, and those with spinal cord injury receiving epidural stimulation. Diagnostic tests include sympathetic inhibition using phenylephrine infusion, cold pressor tests on the hand and foot, Valsalva maneuver, and bladder pressor response. Those with implanted epidural stimulators will use them during testing, while others will receive transcutaneous stimulation. During the study, participants will undergo laboratory diagnostic testing sessions measuring blood pressure, heart rate, skin response, respiration, blood flow, and blood tests for immune markers and stress hormones. Researchers will analyze responses to various tests to assess autonomic nervous system function. The total study participation will occur over multiple sessions, with safety and compliance monitored throughout the process.
CONDITIONS
Brief Title
Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
Who Can Participate
Age: 18Years - 50Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 18 and 50 years
- Spinal cord injury classified as American Spinal Injury Association Impairment Scale A-D
- Neurological injury level from C6 to T8
- Injury occurred more than six months ago
- Both participants with and without implanted epidural spinal cord stimulators are eligible
- Twenty uninjured control participants will also be enrolled
You will not qualify if you...
- History of cardiovascular disease, diabetes, autonomic neuropathies, neurological disorders other than spinal cord injury, or active smoking
- Taking beta-blockers, antihypertensives, or other sympathetically active medications that cannot be paused
- Pregnant or lactating women
- Cognitive issues preventing informed consent
- Body mass index over 30 kg/m2 for uninjured controls
- Taking medications that may interact adversely with phenylephrine
- Any illness or condition judged by the investigator to interfere with study compliance, safety, or results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo a series of laboratory diagnostic tests including sympathetic inhibition tests, sympathetic activation tests above and below the injury level, and autonomic function assessments using either epidural or transcutaneous spinal cord stimulation depending on their group assignment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Loading map...
Research Team
E
Erin Lund
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
A Novel Testing Battery for Preserved Autonomic Regulation Following Spinal Cord Injury and New Translationally Focused Data Representation.
Ryan Solinsky, Kathryn Burns, Jason W Hamner...
https://pubmed.ncbi.nlm.nih.gov/40585014