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NCT Number: NCT07012135

Deciphering Preserved Autonomic Function After Multiple Sclerosis

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location status: Recruiting

Location contact

Erin Lund

CONTACT

[email protected]

507-284-9298

Ryan J. Solinsky, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tests of sympathetic inhibition

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

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

Diagnostic Test

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

Primary outcomes

  1. Valsalva Maneuver Phase II

    Time frame: During single laboratory diagnostic testing session, on average 30 minutes after start of laboratory testing session

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

Secondary outcomes

  1. Beat-to-beat heart rate

    Time frame: Continuous recording during single laboratory diagnostic testing session, from baseline to lab session end, average of 3 hours in duration

    Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.

  2. Beat-to-beat blood pressure

    Time frame: Continuous recording during single laboratory diagnostic testing session, from baseline to lab session end, average of 3 hours in duration

    Non-invasive continuous blood pressure monitors will be used, with changes in systolic and diastolic pressure (in mmHg) from resting baseline measured.

  3. Quantify autonomic dysreflexia and orthostatic hypotension

    Time frame: Baseline, prior to laboratory diagnostic testing session

    Participants will be given the Autonomic Dysfunction Following Spinal Cord Injury questionnaire (score range 0-436, with higher scores indicating more autonomic dysfunction).

  4. Quantify secondary autonomic complications

    Time frame: Baseline, prior to laboratory diagnostic testing session

    Participants will be given the Composite Autonomic Symptom Score (range 0-100, with higher scores indicating more autonomic dysfunction).

  5. Serum Catecholamines

    Time frame: 3x during single laboratory diagnostic testing session - collected at Baseline, pre-pressor test, post-pressor test - pre-pressor & post-pressor timepoint labs collected on average 2.5 & 3 hours post-baseline, respectively

    A series of 3 serum catecholamine draws will occur during the study visit at baseline, pre-pressor test, and post-pressor test to evaluate change in stress hormone.

  6. Serum Cortisol

    Time frame: 3x during single laboratory diagnostic testing session - collected at Baseline, pre-pressor test, post-pressor test - pre-pressor & post-pressor timepoint labs collected on average 2.5 & 3 hours post-baseline, respectively

    A series of 3 serum cortisol draws will occur during the study visit at baseline, pre-pressor test, and post-pressor test to evaluate change in stress hormone.

  7. T-Cell Exhaustion Markers

    Time frame: During single laboratory diagnostic testing session - Baseline

    Blood will be drawn at start of laboratory testing to assess T-cell exhaustion markers by incidence of surface markers including PD-1, TIM-3, LAG3, and CTLA-4 per individual.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Lund

CONTACT

[email protected]

507-284-9298

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: DPAF-MS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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