NCT07210437

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
25mo left

Started Jan 2026

Typical duration 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 Progress11%
Jan 2026Jun 2028

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
4 months until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

September 29, 2025

Last Update Submit

February 13, 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 (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Chronic Spinal Cord Injury

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

Acute Spinal Cord Injury

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

Interventions

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.

Acute Spinal Cord InjuryChronic Spinal Cord Injury
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).

Acute Spinal Cord InjuryChronic Spinal Cord Injury
Testing of below level sympathetic activationDIAGNOSTIC_TEST

Cold pressor test of the foot and bladder pressor response will be tested.

Acute Spinal Cord InjuryChronic Spinal Cord Injury

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

  • Solinsky R, Burns K, Hamner JW, Singer W, Taylor JA. Characterizing preserved autonomic regulation following spinal cord injury: Methods of a novel concerted testing battery and illustrative examples of a new translationally focused data representation. medRxiv [Preprint]. 2024 Jun 1:2024.05.31.24308290. doi: 10.1101/2024.05.31.24308290.

    PMID: 38854077BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

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

January 31, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

US(1)