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RecruitingNCT07012135DPAF-MSUpdated May 28, 2026

Deciphering Preserved Autonomic Function After Multiple Sclerosis

An interventional study of Tests of sympathetic inhibition and Tests of sympathetic activation in Multiple Sclerosis, Control Subjects and Autonomic Dysreflexia, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis
  • Control Subjects
  • Autonomic Dysreflexia
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
13 participants (estimated)

Study arms

  • Experimental
    Individuals with multiple sclerosis

    Diagnostic Test: Tests of sympathetic inhibition · Diagnostic Test: Tests of sympathetic activation · Diagnostic Test: Testing of autonomic dysreflexia

  • Experimental
    Individuals without multiple sclerosis

    Diagnostic Test: Tests of sympathetic inhibition · Diagnostic Test: Tests of sympathetic activation · Diagnostic Test: Testing of autonomic dysreflexia

Interventions

  • Diagnostic testTests 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.

  • Diagnostic testTests 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).

  • Diagnostic testTesting of autonomic dysreflexia

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

05

What researchers measure

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.

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

Secondary outcomes

  1. Beat-to-beat heart rate

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

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

  2. Beat-to-beat blood pressure

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

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

  3. Quantify autonomic dysreflexia and orthostatic hypotension

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

    Time frame: Baseline, prior to laboratory diagnostic testing session

  4. Quantify secondary autonomic complications

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

    Time frame: Baseline, prior to laboratory diagnostic testing session

  5. Serum Catecholamines

    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.

    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

  6. Serum Cortisol

    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.

    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

  7. T-Cell Exhaustion Markers

    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.

    Time frame: During single laboratory diagnostic testing session - Baseline

06

Study locations

1 of 1 sites recruiting
  • Mayo Clinic
    Rochester, Minnesota 55902, United States
    • Erin Lund · Contact · lund.erin@mayo.edu · 507-284-9298
    • Ryan J. Solinsky, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07012135
Lead sponsor
Mayo Clinic
Responsible party
Ryan J. Solinsky (M.D., Mayo Clinic) — Principal investigator
First posted
Jun 10, 2025
Start date
Sep 17, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 28, 2026

Study contacts

Erin Lund
Contact
lund.erin@mayo.edu
507-284-9298
Ryan J. Solinsky, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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