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/37947438/Actively Recruiting
Led by Mayo Clinic · Updated on 2026-05-28
80
Participants Needed
1
Research Sites
13 weeks
Total Duration
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
Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
E
Erin Lund
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Mayo Clinic
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Transcutaneous stimulation | Baseline testing | Epidural stimulation |
|---|---|---|---|
| What it is | Diagnostic assessments using transcutaneous spinal cord stimulation in participants without implanted stimulators. | Standard autonomic function tests performed without spinal cord stimulation under controlled laboratory conditions. | Diagnostic assessments using existing implanted epidural spinal cord stimulator during autonomic testing. |
| Role in trial | Investigates autonomic response under noninvasive stimulation in SCI individuals. | Serves as the reference diagnostic condition to compare effects of stimulation. | Assesses autonomic modulation when existing epidural stimulator is used during testing. |
| Primary use | Evaluate above and below level autonomic activation using noninvasive stimulation. | Establish baseline sympathetic inhibition and activation responses. | Examine autonomic regulation with implanted epidural stimulator during diagnostics. |
| How it is performed | Cold pressor and Valsalva maneuvers combined with transcutaneous spinal cord stimulation during autonomic testing. | Sympathetic inhibition and activation tests such as phenylephrine infusion, Mayer wave analysis, cold pressor and Valsalva maneuvers without stimulation. | Same autonomic tests administered while using existing implanted epidural stimulator. |
| Evidence status | Early data suggest transcutaneous spinal cord stimulation may modulate cardiovascular autonomic responses after SCI. | Baseline autonomic testing is established clinical practice for assessment of sympathetic function. | Limited evidence supports use of epidural stimulation for modulating autonomic function in SCI, primarily derived from case studies and device reports. |
| Important risks | Potential for exaggerated autonomic responses such as dysreflexia during stimulation. | Risks associated with provocative autonomic testing such as blood pressure spikes. | Uncertain risk profile when using implanted stimulators during testing; possibility of adverse autonomic effects. |
| Important limitations | Noninvasive stimulation may not replicate effects seen with implanted epidural systems. | Baseline tests do not reveal effects of spinal stimulation on autonomic control. | Participants must already have an implanted device; limits generalizability to broader SCI population. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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Ryan Solinsky, Kathryn Burns, Christopher Tuthill...
https://pubmed.ncbi.nlm.nih.gov/37947438/Ryan Solinsky, Kathryn Burns, Jason W Hamner...
https://pubmed.ncbi.nlm.nih.gov/40585014/Mayo Clinic
Lead Sponsor