Deciphering Preserved Autonomic Function After Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tests of sympathetic inhibition, Tests of sympathetic activation, Testing of autonomic dysreflexia.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Control Subjects, Autonomic Dysreflexia. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Tests 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 test Tests 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 test Testing of autonomic dysreflexia
Cold pressor test of the foot and bladder pressor response will be tested.
Primary outcome measures
- Valsalva Maneuver Phase II [Time frame: During single laboratory diagnostic testing session, on average 30 minutes after start of laboratory testing session]
Secondary outcome measures (7)
- Beat-to-beat heart rate [Time frame: 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 [Time frame: 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 [Time frame: Baseline, prior to laboratory diagnostic testing session]
- Quantify secondary autonomic complications [Time frame: Baseline, prior to laboratory diagnostic testing session]
- Serum Catecholamines [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]
- Serum Cortisol [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]
- T-Cell Exhaustion Markers [Time frame: During single laboratory diagnostic testing session - Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT07012135 · 24-007459