Clinical trial NCT07012135: Deciphering Preserved Autonomic Function After Multiple Sclerosis
Official title: Deciphering Preserved Autonomic Function After Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Control Subjects
Autonomic Dysreflexia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Valsalva Maneuver Phase II
timeFrame: During single laboratory diagnostic testing session, on average 30 minutes after start of laboratory testing session
Secondary outcomes:
measure: Beat-to-beat heart rate
timeFrame: Continuous recording during single laboratory diagnostic testing session, from baseline to lab session end, average of 3 hours in duration
measure: Beat-to-beat blood pressure
timeFrame: Continuous recording during single laboratory diagnostic testing session, from baseline to lab session end, average of 3 hours in duration
measure: Quantify autonomic dysreflexia and orthostatic hypotension
timeFrame: Baseline, prior to laboratory diagnostic testing session
measure: Quantify secondary autonomic complications
timeFrame: Baseline, prior to laboratory diagnostic testing session
measure: Serum Catecholamines
timeFrame: 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
measure: Serum Cortisol
timeFrame: 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
measure: T-Cell Exhaustion Markers
timeFrame: During single laboratory diagnostic testing session - Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: