Deciphering Preserved Autonomic Function After Multiple Sclerosis
DPAF-MS
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-sclerosis
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2025
CompletedFirst Posted
Study publicly available on registry
June 10, 2025
CompletedStudy Start
First participant enrolled
September 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 5, 2026
March 1, 2026
1.3 years
May 14, 2025
March 3, 2026
Conditions
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 single laboratory diagnostic testing session, on average 30 minutes after start of laboratory testing session
Secondary Outcomes (7)
Beat-to-beat heart rate
Continuous recording during single laboratory diagnostic testing session, from baseline to lab session end, average of 3 hours in duration
Beat-to-beat blood pressure
Continuous recording during single laboratory diagnostic testing session, from baseline to lab session end, average of 3 hours in duration
Quantify autonomic dysreflexia and orthostatic hypotension
Baseline, prior to laboratory diagnostic testing session
Quantify secondary autonomic complications
Baseline, prior to laboratory diagnostic testing session
Serum Catecholamines
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
- +2 more secondary outcomes
Study Arms (2)
Individuals with multiple sclerosis
EXPERIMENTALIndividuals without multiple sclerosis
EXPERIMENTALInterventions
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.
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).
Cold pressor test of the foot and bladder pressor response will be tested.
Eligibility Criteria
You may qualify if:
- years old
- clinically confirmed diagnosis of multiple sclerosis -OR- uninjured control
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55902, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
- M.D.
Study Record Dates
First Submitted
May 14, 2025
First Posted
June 10, 2025
Study Start
September 17, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share