Deciphering Preserved Autonomic Function After Multiple Sclerosis

RecruitingNot a drug-phase studyMS (type not specified)NCT07012135

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Tests of sympathetic inhibition
  • Tests of sympathetic activation
  • Testing of autonomic dysreflexia

What it measured

Main measures

  • Valsalva Maneuver Phase II

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

Other measures (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-

  • Serum Cortisol

    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-

  • T-Cell Exhaustion Markers

    During single laboratory diagnostic testing session - Baseline

Who could take part

MS (type not specified) · 18 to 50

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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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History

    1. Started

      Sept 2025

    2. Main results due

      Dec 2026

    3. Finished

      Dec 2026

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