Recruiting

Spinal Cord Stimulation

Sponsor:

Mayo Clinic

Code:

NCT07210411

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Tests of sympathetic inhibition

Tests of above level sympathetic activation

Testing of below level sympathetic activation

Epidural stimulation

Transcutaneous stimulation

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Study ID

NCT07210411

Start date

Mar 5, 2026

Status verified date

Dec, 2025

Completion date

Apr 1, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion criteria

  • Age 18-50.
  • American Spinal Injury Association Impairment Scale A-D,64 to encompass a representational spectrum of autonomic dysfunction after spinal cord injury.
  • Neurological level of injury, C6-T8, as defined by the International Standards for Neurological Classification of Spinal Cord Injury.64 Incorporating level of injury over this broad range to capture the spectrum of autonomic dysfunction. Individuals with injuries below T8 will not be included to ensure transcutaneous spinal cord stimulation does not occur over the injury/glial scar, where it may have altered properties. The C6 level was chosen to ensure hand cold pressor stimuli triggers above level sympathetic activation.
  • Time since injury of greater than six months, given early changes in spinal cord connectivity and recovery prior to this.
  • Both individuals with and without currently implanted epidural spinal cord stimulators will be enrolled.
  • Twenty uninjured controls will also be enrolled.

Exclusion criteria

  • History of clinically diagnosed cardiovascular disease, diabetes, autonomic neuropathies, neurological disorders (with exception of spinal cord injury for individuals in those cohorts), or are active smokers.
  • Individuals who are taking betablockers, antihypertensives, or other sympathetically active medications which they are unable to hold.
  • Women who are pregnant or lactating, given known hormonal influences on autonomic regulation.65,66
  • Cognitive issues preventing informed consent for participation.
  • Body mass index >30 kg/m2 for the uninjured controls only given increased risk of prediabetes and potential confounding normative values.
  • taking or being administered a medication known to potentially have adverse interactions with phenylephrine
  • in the judgement of the principal investigator, any illness or condition that will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

Tests of sympathetic inhibition

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

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

Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.

Epidural stimulation

Currently implanted epidural stimulation will be used during diagnostic testing.

Transcutaneous stimulation

Transcutaneous stimulation will be used for participants with spinal cord injury without an implanted stimulator during diagnostic testing.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Erin Lund

507-284-9298lund.erin@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Erin Lund

507-284-9298lund.erin@mayo.edu

Principal Investigator:

Ryan J. Solinsky, MD

More Information

Sponsor

Mayo Clinic

Last update posted

May 28, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-28.