NCT07210411

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
60mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Mar 2026Apr 2031

First Submitted

Initial submission to the registry

September 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

March 5, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2031

Last Updated

March 9, 2026

Status Verified

December 1, 2025

Enrollment Period

4.8 years

First QC Date

September 29, 2025

Last Update Submit

March 5, 2026

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

  • Valsalva Maneuver Phase II

    Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.

    During laboratory diagnostic testing session

Secondary Outcomes (8)

  • Beat-to-beat heart rate

    During laboratory diagnostic testing session

  • Beat-to-beat blood pressure

    During laboratory diagnostic testing session

  • Continuous galvanic skin response

    During laboratory diagnostic testing session

  • Quantify autonomic dysreflexia and orthostatic hypotension

    Baseline, prior to laboratory diagnostic testing session

  • Respiration

    During laboratory diagnostic testing session

  • +3 more secondary outcomes

Study Arms (3)

Control

EXPERIMENTAL

Control participants without a spinal cord injury

Diagnostic Test: Tests of sympathetic inhibitionDiagnostic Test: Tests of above level sympathetic activationDiagnostic Test: Testing of below level sympathetic activation

Transcutaneous stimulation

EXPERIMENTAL

Individuals with spinal cord injury receiving transcutaneous stimulation

Diagnostic Test: Tests of sympathetic inhibitionDiagnostic Test: Tests of above level sympathetic activationDiagnostic Test: Testing of below level sympathetic activationDevice: Transcutaneous stimulation

Epidural stimulation

EXPERIMENTAL

Individuals with spinal cord injury receiving epidural stimulation

Diagnostic Test: Tests of sympathetic inhibitionDiagnostic Test: Tests of above level sympathetic activationDiagnostic Test: Testing of below level sympathetic activationDevice: Epidural stimulation

Interventions

Epidural stimulationDEVICE

Currently implanted epidural stimulation will be used during diagnostic testing.

Epidural stimulation
Tests of sympathetic inhibitionDIAGNOSTIC_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.

ControlEpidural stimulationTranscutaneous stimulation
Tests of above level sympathetic activationDIAGNOSTIC_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).

ControlEpidural stimulationTranscutaneous stimulation
Testing of below level sympathetic activationDIAGNOSTIC_TEST

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

ControlEpidural stimulationTranscutaneous stimulation
Transcutaneous stimulationDEVICE

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

Transcutaneous stimulation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (2)

  • Solinsky R, Burns K, Tuthill C, Hamner JW, Taylor JA. Transcutaneous spinal cord stimulation and its impact on cardiovascular autonomic regulation after spinal cord injury. Am J Physiol Heart Circ Physiol. 2024 Jan 1;326(1):H116-H122. doi: 10.1152/ajpheart.00588.2023. Epub 2023 Nov 10.

    PMID: 37947438BACKGROUND

  • Solinsky R, Burns K, Hamner JW, Veith DD, Singer W, Taylor JA. A Novel Testing Battery for Preserved Autonomic Regulation Following Spinal Cord Injury and New Translationally Focused Data Representation. Top Spinal Cord Inj Rehabil. 2025 Spring;31(2):50-61. doi: 10.46292/sci24-00071. Epub 2025 Jun 19.

    PMID: 40585014BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Ryan Solinsky, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary Pohlkamp

CONTACT

507-422-0140pohlkamp.zachary@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2025

First Posted

October 7, 2025

Study Start

March 5, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

April 1, 2031

Last Updated

March 9, 2026

Record last verified: 2025-12

Locations

US(1)