Autonomic Function Testing for Multiple Sclerosis

(DPAF-MS Trial)

Overseen By Zachary Pohlkamp

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Phenylephrine interactors

Disqualifiers: Cardiovascular, Respiratory, Diabetes, BMI ≥ 35, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how multiple sclerosis affects the autonomic nervous system, which controls functions like blood pressure and bladder health. Researchers will assess the body's response to signals regulating these functions through autonomic function testing. The trial includes two groups: one with individuals who have multiple sclerosis and another with those who do not. Individuals clinically diagnosed with multiple sclerosis or those who are healthy without injuries may be suitable participants. As an unphased trial, this study provides a unique opportunity to contribute to understanding multiple sclerosis and its impact on the autonomic nervous system.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that might interact badly with phenylephrine. It's best to discuss your current medications with the trial team.

What prior data suggests that these autonomic function tests are safe?

Research has shown that testing for autonomic dysreflexia in people with multiple sclerosis (MS) is generally safe. One study found that 42% of MS patients experienced issues with heart and blood pressure control. This indicates that many people with MS face these problems, but the tests themselves are not harmful.

Studies on tests that assess the body's response to stress have shown that while heart and blood pressure issues can worsen MS, the tests do not add any risk. In one study, a drop in heart rate occurred after treatment, but no serious side effects were observed, suggesting the tests are well-tolerated.

For tests examining how the body calms down, research has shown that MS patients often exhibit lower nerve activity, but the tests do not introduce new risks. Another study found that 34% of patients had no response in the skin of at least one limb, attributed to MS rather than the test.

In summary, these tests have been safely used in people with MS to gain insights into their condition. While MS can affect the nervous system, participating in these tests does not appear to pose any significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these tests because they aim to uncover how autonomic nervous system functions are affected in people with multiple sclerosis (MS). Unlike existing treatments that primarily focus on managing symptoms or slowing disease progression, these tests explore the autonomic dysreflexia, sympathetic activation, and inhibition, providing new insights into MS's impact on bodily systems. This could lead to a deeper understanding of MS and potentially open the door for innovative ways to manage or treat the condition.

What evidence suggests that this trial's tests could be effective for autonomic dysfunction in multiple sclerosis?

Research has shown that people with multiple sclerosis often experience issues with their autonomic nervous system, which controls functions like blood pressure. Studies indicate that 42% to 65% of these patients face heart and blood pressure regulation problems. About 34% have difficulty with their body's stress response, as demonstrated by tests on their skin's reaction to stress. This trial will test autonomic dysreflexia, sympathetic activation, and sympathetic inhibition in individuals with and without multiple sclerosis. Balancing these signals might help reduce inflammation and other symptoms of multiple sclerosis. Overall, these tests aim to enhance understanding and improve nervous system function in people with this condition. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with clinically diagnosed multiple sclerosis (MS) who experience autonomic dysreflexia, a condition affecting blood pressure and bladder function. It also includes control subjects without MS. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.

Inclusion Criteria

I have been diagnosed with multiple sclerosis or I am a healthy control.

I am between 18 and 50 years old.

Exclusion Criteria

I have symptoms of heart, lung, nerve, or diabetes needing treatment.

I am on medication that may not mix well with phenylephrine.

Having a body mass index (BMI) ≥ 35 kg/m2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Laboratory Testing

Participants undergo laboratory-based tests to probe autonomic responses, including continuous recordings and blood draws

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after laboratory testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests how well the autonomic nervous system, which controls vital functions like blood pressure and skin blood flow, works in people with MS compared to healthy controls. It involves laboratory-based experiments that measure the body's ability to activate and inhibit autonomic responses.

How Is the Trial Designed?

Group I: Individuals without multiple sclerosis Experimental Treatment 3 Interventions

Group II: Individuals with multiple sclerosis Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4581177/

Autonomic Dysregulation in Multiple Sclerosis - PMC According to their results, cardiovascular autonomic dysfunction was present in 42% of included patients based on the definition of minimum one pathological ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3093232/

Assessment of autonomic nervous system dysfunction in ... Sixty-five per cent of the patients presented with AD and 29% of these patients had abnormal SSR results. MS patients with high EDSS values (EDSS>4) and longer ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07012135?term=multiple+sclerosis&lastUpdPost=2014-09-10_

Deciphering Preserved Autonomic Function After Multiple ... The investigators anticipate that those with autonomic dysfunction with multiple sclerosis will exhibit abnormalities in these precise metrics.

4. withpower.com withpower.com/trial/phase-autonomic-dysreflexia-6-2025-10395

Autonomic Function Testing for Multiple Sclerosis This study looks to characterize gradients of dysfunction in the autonomic nervous system in patients with clinically diagnosed multiple sclerosis.

5. karger.com karger.com/ene/article/48/1/1/124879/Autonomic-Dysfunction-in-Multiple-Sclerosis

Autonomic Dysfunction in Multiple Sclerosis: Correlation ... Ninety percent of the patients had symptoms related with autonomic dysfunction, and 45.5 % had abnormal results in cardiovascular autonomic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8152175/

Evaluation and Management of Autonomic Dysreflexia and ... To accurately diagnose OH in individuals with SCI, perform an orthostatic challenge evaluation (e.g., sit-up test or head-up tilt test). (Level - V; Strength - ...

7. neurology.org neurology.org/doi/10.1212/WNL.96.15_supplement.2778

Exploring the Role of Autonomic Dysfunction as a ... Objective:To evaluate the relationship between fatigue severity and cardiovascular autonomic function in patients with multiple sclerosis (MS).