Deciphering Preserved Autonomic Function After Multiple Sclerosis

NCT ID: NCT07012135

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-17
• Study Completion Date: 2026-01-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Individuals with multiple sclerosis

Group Type: EXPERIMENTAL

Tests of sympathetic inhibition

Intervention Type: DIAGNOSTIC_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.

Tests of sympathetic activation

Intervention Type: DIAGNOSTIC_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).

Testing of autonomic dysreflexia

Intervention Type: DIAGNOSTIC_TEST

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

Individuals without multiple sclerosis

Group Type: EXPERIMENTAL

Tests of sympathetic inhibition

Intervention Type: DIAGNOSTIC_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.

Tests of sympathetic activation

Intervention Type: DIAGNOSTIC_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).

Testing of autonomic dysreflexia

Intervention Type: DIAGNOSTIC_TEST

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

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.

Intervention Type: DIAGNOSTIC_TEST

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).

Intervention Type: DIAGNOSTIC_TEST

Testing of autonomic dysreflexia

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ryan J. Solinsky

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mayo Clinic

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zachary Pohlkamp

Role: CONTACT

pohlkamp.zachary@mayo.edu

507-422-0140

Facility Contacts

Zachary Pohlkamp

Role: primary

pohlkamp.zachary@mayo.edu

507-422-0140

Other Identifiers

24-007459

Identifier Type: -

Identifier Source: org_study_id