Multiple SclerosisDPAF-MSNCT07012135
Deciphering Preserved Autonomic Function After Multiple Sclerosis
A study testing Tests of sympathetic inhibition, Tests of sympathetic activation and Testing of autonomic dysreflexia in people with Multiple Sclerosis and Control Subjects, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Control Subjects, Autonomic Dysreflexia
- What is being tested?
- Tests of sympathetic inhibition, Tests of sympathetic activation and Testing of autonomic dysreflexia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 years old
- clinically confirmed diagnosis of multiple sclerosis -OR- uninjured control
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Erin Lund, 507-284-9298, lund.erin@mayo.edu
Ryan J. Solinsky, MD
About this study
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.
- Conditions
- Multiple Sclerosis, Control Subjects, Autonomic Dysreflexia
- Being tested
- Tests of sympathetic inhibition, Tests of sympathetic activation, Testing of autonomic dysreflexia
- Medical subject headings
- Multiple Sclerosis, Autonomic Dysreflexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tests of sympathetic inhibitionDiagnostic test
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.
Tests of sympathetic activationDiagnostic test
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).
Testing of autonomic dysreflexiaDiagnostic test
Cold pressor test of the foot and bladder pressor response will be tested.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with multiple sclerosis | Experimental | Not described Receives: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of sympathetic activation; Diagnostic Test: Testing of autonomic dysreflexia |
| Individuals without multiple sclerosis | Experimental | Not described Receives: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of sympathetic activation; Diagnostic Test: Testing of autonomic dysreflexia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During single laboratory diagnostic testing session, on average 30 minutes after start of laboratory testing session
Secondary outcomes (7)
Beat-to-beat heart rate
Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.
Measured: 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
Non-invasive continuous blood pressure monitors will be used, with changes in systolic and diastolic pressure (in mmHg) from resting baseline measured.
Measured: 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
Participants will be given the Autonomic Dysfunction Following Spinal Cord Injury questionnaire (score range 0-436, with higher scores indicating more autonomic dysfunction).
Measured: Baseline, prior to laboratory diagnostic testing session
Quantify secondary autonomic complications
Participants will be given the Composite Autonomic Symptom Score (range 0-100, with higher scores indicating more autonomic dysfunction).
Measured: Baseline, prior to laboratory diagnostic testing session
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.
Measured: 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
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.
Measured: 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
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.
Measured: During single laboratory diagnostic testing session - Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start17 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan J. Solinsky, Mayo Clinic
- Investigators
- Ryan J. Solinsky, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012135
- Sponsor's protocol ID
- 24-007459
- Acronym
- DPAF-MS
- Status last verified
- May 2026
- First submitted
- 14 May 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering Preserved Autonomic Function After Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07012135
- Acronym / sponsor ID
- DPAF-MS / 24-007459
- Conditions
- Multiple Sclerosis, Control Subjects, Autonomic Dysreflexia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with multiple sclerosis | Experimental | Diagnostic Test: Tests of sympathetic inhibition, Diagnostic Test: Tests of sympathetic activation, Diagnostic Test: Testing of autonomic dysreflexia |
| Individuals without multiple sclerosis | Experimental | Diagnostic Test: Tests of sympathetic inhibition, Diagnostic Test: Tests of sympathetic activation, Diagnostic Test: Testing of autonomic dysreflexia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-50 years old
- clinically confirmed diagnosis of multiple sclerosis -OR- uninjured control
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tests of sympathetic inhibitionBolus 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 | Individuals with multiple sclerosis, Individuals without multiple sclerosis |
| Tests of sympathetic activationCold 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 | Individuals with multiple sclerosis, Individuals without multiple sclerosis |
| Testing of autonomic dysreflexiaCold pressor test of the foot and bladder pressor response will be tested. | Diagnostic test | Individuals with multiple sclerosis, Individuals without multiple sclerosis |
Primary outcome
Valsalva Maneuver Phase II
Time frame: During single laboratory diagnostic testing session, on average 30 minutes after start of laboratory testing session
Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan J. Solinsky, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tests of sympathetic inhibition, Tests of sympathetic activation and Testing of autonomic dysreflexia in people with Multiple Sclerosis and Control Subjects, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Lund (507-284-9298, lund.erin@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Valsalva Maneuver Phase II (time frame: During single laboratory diagnostic testing session, on average 30 minutes after start of laboratory testing session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.