Understanding preserved autonomic function after multiple sclerosis

Deciphering Preserved Autonomic Function After Multiple Sclerosis

This project will test whether people with multiple sclerosis have preserved or abnormal blood pressure and other autonomic responses compared with uninjured controls.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 13 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT07012135 on ClinicalTrials.gov

What this trial studies

Researchers will bring adults with clinically confirmed multiple sclerosis and uninjured control volunteers to a Mayo Clinic laboratory to perform detailed autonomic function tests focused on blood pressure regulation. Multiple parallel recordings will be taken during maneuvers that provoke sympathetic inhibition and activation, and tests related to skin blood flow and bladder-related autonomic control will be included. Participants with major cardiovascular, respiratory, peripheral neurological or autonomic disease, pregnancy or a BMI ≥35, or taking medications that interact with phenylephrine will be excluded. The goal is to map precise physiological metrics and see how they differ across a spectrum of autonomic function in people with and without MS.

Who should consider this trial

Good fit: Adults 18–50 years old with a clinically confirmed diagnosis of multiple sclerosis (or healthy uninjured control volunteers) who do not have active cardiovascular, respiratory, peripheral neurological or autonomic disease, are not pregnant or lactating, have BMI under 35, and are not taking medications that interact with phenylephrine are ideal candidates.

Not a fit: People outside the 18–50 age range, those with active cardiovascular disease, diabetes or other autonomic/peripheral nervous system disorders, pregnant or lactating individuals, people with BMI ≥35, or those taking medications that interact with phenylephrine are unlikely to benefit or be eligible, and this project does not provide therapeutic treatment.

Why it matters

Potential benefit: If successful, the work could identify objective physiological markers to detect autonomic problems earlier and help guide future personalized management of blood pressure and bladder issues in MS.

How similar studies have performed: Previous studies have documented autonomic dysfunction in multiple sclerosis, but combining high-precision, parallel laboratory recordings and targeted sympathetic inhibition/activation protocols is a relatively novel, more detailed approach.

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

Where this trial is running

Rochester, Minnesota

• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Study coordinator: Zachary Pohlkamp

Conditions Multiple Sclerosis; Control Subjects; Autonomic Dysreflexia