Recruiting

Autonomic Dysfunction

Sponsor:

Mayo Clinic

Code:

NCT07012135

Conditions

Multiple Sclerosis

Control Subjects

Autonomic Dysreflexia

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Tests of sympathetic inhibition

Tests of sympathetic activation

Testing of autonomic dysreflexia

Study Details

Brief summary:

This study looks to characterize gradients of dysfunction in the autonomic nervous system in patients with clinically diagnosed multiple sclerosis. The autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with multiple sclerosis typically suffer. Focusing on blood pressure regulation, the most precise metric with broad clinical applicability, the investigators will perform laboratory-based tests to probe the body's ability to generate autonomic responses. For both individuals with multiple sclerosis and uninjured controls, laboratory-based experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate signals. The investigators anticipate that those with autonomic dysfunction with multiple sclerosis will exhibit abnormalities in these precise metrics. The investigators will look to see if any substantial connections exist between different degrees of preserved autonomic function and secondary autonomic complications from multiple sclerosis. In accomplishing this, the investigators hope to give scientists important insights to how the autonomic nervous system works after multiple sclerosis and give physicians better tools to manage these secondary autonomic complications.

Conditions

Multiple Sclerosis

Control Subjects

Autonomic Dysreflexia

Study ID

NCT07012135

Start date

Sep 17, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18-50 years old
  • clinically confirmed diagnosis of multiple sclerosis -OR- uninjured control

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
  • having a body mass index (BMI) ≥ 35 kg/m2
  • taking or being administered a medication known to potentially have adverse interactions with phenylephrine
  • in the judgement of the principal investigator or clinical collaborator, 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

13 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Individuals with multiple sclerosis

experimental: Individuals without multiple sclerosis

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 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 autonomic dysreflexia

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

Primary outcome measure

  • Valsalva Maneuver Phase II [ Time Frame: During single laboratory diagnostic testing session, on average 30 minutes after start of laboratory testing session ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Principal Investigator:

Ryan J. Solinsky, MD

More Information

Sponsor

Mayo Clinic

Last update posted

May 28, 2026

Last verified

May, 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.