Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07210411
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Tests of sympathetic inhibition — DIAGNOSTIC_TEST
    Bolus phenylephrine infusion using the Oxford technique will generate the need to inhibit sympathetic activity. Similarly, resting state Mayer waves will be assessed with regard to heart rate and blood pressure responses.
  • Tests of above level sympathetic activation — DIAGNOSTIC_TEST
    Cold pressor test of the hand will be used to cause sympathetic activation. Valsalva's maneuver will assess the ability to buffer against blood pressure fall (phase II).
  • Testing of below level sympathetic activation — DIAGNOSTIC_TEST
    Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
  • Epidural stimulation — DEVICE
    Currently implanted epidural stimulation will be used during diagnostic testing.
  • Transcutaneous stimulation — DEVICE
    Transcutaneous stimulation will be used for participants with spinal cord injury without an implanted stimulator during diagnostic testing.

Study Details

The purpose of this research is to learn about how the participant's body is able to balance changes in blood pressure, and how spinal cord stimulation affects these changes as well as immune \& cardiovascular function in participants with spinal cord injury.

Key Dates

Start date
Mar 5, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2030
Completion
Apr 1, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Control
    Control participants without a spinal cord injury
  • Experimental: Transcutaneous stimulation
    Individuals with spinal cord injury receiving transcutaneous stimulation
  • Experimental: Epidural stimulation
    Individuals with spinal cord injury receiving epidural stimulation

Primary Outcome Measure

Valsalva Maneuver Phase II [ Time Frame: During laboratory diagnostic testing session ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Erin Lund
[email protected]
507-284-9298
Ryan J. Solinsky, MD (PRINCIPAL_INVESTIGATOR)

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