Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT07210437

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tests of sympathetic inhibition

Tests of above level sympathetic activation

Testing of below level sympathetic activation

Study Details

Brief summary:

The purpose of this research is to learn about how the body is able to balance changes in blood pressure, how that changes over time, and how these changes impact a participant's risk of developing medical problems.

Conditions

Spinal Cord Injuries

Study ID

NCT07210437

Start date

Jan 31, 2026

Status verified date

Feb, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion criteria

  • 18-75 years old
  • Spinal cord injury with neurological level of injury from C6-T12
  • ASIA Impairment Scale A-D.
  • Either acute SCI <3 months prior (n=10) or chronic SCI (>1 year since injury, n=8).

Exclusion criteria

  • Symptoms of cardiovascular (including, but not limited to: hypertension, stroke, chest pain, etc.), respiratory, peripheral neurological or autonomic disease (particularly diabetes mellitus requiring treatment);
  • Women who are pregnant or lactating
  • 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

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Chronic Spinal Cord Injury

experimental: Acute Spinal Cord Injury

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 will be tested.

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

Feb, 2026

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.