Deciphering Preserved Autonomic Function After Multiple Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMayo Clinic

About this trial

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

This trial accepts healthy volunteers

Qualifiers

18-50 years old

clinically confirmed diagnosis of multiple sclerosis -OR- uninjured control

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

13 Participants
are divided into 2 treatment groups
Group A: Individuals with multiple sclerosisExperimental treatment 3 interventions
Group B: Individuals without multiple sclerosisExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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