ClinicalTrials.gg
RecruitingNCT07012135DPAF-MSUpdated May 28, 2026

Deciphering Preserved Autonomic Function After Multiple Sclerosis

An interventional study of Tests of sympathetic inhibition and Tests of sympathetic activation in Multiple Sclerosis, Control Subjects and Autonomic Dysreflexia, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.

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Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,192 studies in Multiple Sclerosis with a site in United States — 184 open to participants now, 259 under way, 23 of them phase 3. Multiple Sclerosis · United States.

Planned enrollment
754th of 879
13 · median 50
Started
2025
with 56 others
No phase
381 of 1,192
69 open now
Primary completion
2026-12
later than 73 of 256 live
Registered
1,113th of 1,192
by date

Among the 1,192 studies in Multiple Sclerosis with a site in United States, this one is the 754th largest by planned enrollment of the 879 interventional ones that give a count, is one of 57 that started in 2025, is one of 381 with no phase, reaches primary completion later than 73 of the 256 other live ones, and was the 1,113th registered.

Multiple Sclerosis

3,269 studies on the registry are indexed under Multiple Sclerosis; 663 are open to participants now.

Browse Multiple Sclerosis studies →

Open to participants now

184 of the 1,192 studies in Multiple Sclerosis with a site in United States are open now. Recruiting first, the newest first:

179 more — sign in →

All 184 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 431 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 212 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.

This study: 18 Years to 50 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,192 studies in Multiple Sclerosis with a site in United States, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Multiple Sclerosis
  • Control Subjects
  • Autonomic Dysreflexia
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-50 years old
  • clinically confirmed diagnosis of multiple sclerosis -OR- uninjured control

Exclusion criteria

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 (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
13 participants (estimated)

Study arms

  • Experimental
    Individuals with multiple sclerosis

    Diagnostic Test: Tests of sympathetic inhibition · Diagnostic Test: Tests of sympathetic activation · Diagnostic Test: Testing of autonomic dysreflexia

  • Experimental
    Individuals without multiple sclerosis

    Diagnostic Test: Tests of sympathetic inhibition · Diagnostic Test: Tests of sympathetic activation · Diagnostic Test: Testing of autonomic dysreflexia

Interventions

  • Diagnostic testTests 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 testTests 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 testTesting of autonomic dysreflexia

    Cold pressor test of the foot and bladder pressor response will be tested.

06

What researchers measure

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

  5. Serum Catecholamines

    A series of 3 serum catecholamine draws will occur during the study visit at baseline, pre-pressor test, and post-pressor test to evaluate change in stress hormone.

    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

  6. Serum Cortisol

    A series of 3 serum cortisol draws will occur during the study visit at baseline, pre-pressor test, and post-pressor test to evaluate change in stress hormone.

    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

  7. T-Cell Exhaustion Markers

    Blood will be drawn at start of laboratory testing to assess T-cell exhaustion markers by incidence of surface markers including PD-1, TIM-3, LAG3, and CTLA-4 per individual.

    Time frame: During single laboratory diagnostic testing session - Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.

Of 849 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 15 months is below that.

Counting every sponsor, half of 871 studies reached it within 21 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2025
First posted
Jun 10, 2025
StartActual
Sep 17, 2025
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
May 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07012135
Lead sponsor
Mayo Clinic
Responsible party
Ryan J. Solinsky (M.D., Mayo Clinic) — Principal investigator
First posted
Jun 10, 2025
Start date
Sep 17, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 28, 2026

Study contacts

Erin Lund
Contact
lund.erin@mayo.edu
507-284-9298
Ryan J. Solinsky, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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