Spinal Cord InjuriesNCT07210437
Longitudinal Autonomic Characterization as a Predictor for Secondary Medical Complications Post-SCI
A study testing Tests of sympathetic inhibition, Tests of above level sympathetic activation and Testing of below level sympathetic activation in people with Spinal Cord Injuries, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to learn about how the body is able to balance changes in blood pressure, how that changes over time, and how these changes impact a participant's risk of developing medical problems. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Tests of sympathetic inhibition, Tests of above level sympathetic activation and Testing of below level sympathetic activation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2026to 1 Jun 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old
- Spinal cord injury with neurological level of injury from C6-T12
- ASIA Impairment Scale A-D.
- Either acute SCI <3 months prior (n=10) or chronic SCI (>1 year since injury, n=8).
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
- Taking or being administered a medication known to potentially have adverse interactions with phenylephrine
- In the judgement of the principal investigator, 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, 55905
Erin Lund, 507-284-9298, lund.erin@mayo.edu
Ryan J. Solinsky, MD
About this study
The purpose of this research is to learn about how the body is able to balance changes in blood pressure, how that changes over time, and how these changes impact a participant's risk of developing medical problems.
- Conditions
- Spinal Cord Injuries
- Being tested
- Tests of sympathetic inhibition, Tests of above level sympathetic activation, Testing of below level sympathetic activation
- Medical subject headings
- Spinal Cord Injuries
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 above level 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 below level sympathetic activationDiagnostic test
Cold pressor test of the foot and bladder pressor response will be tested.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Spinal Cord Injury | Experimental | Not described Receives: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of above level sympathetic activation; Diagnostic Test: Testing of below level sympathetic activation |
| Acute Spinal Cord Injury | Experimental | Not described Receives: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of above level sympathetic activation; Diagnostic Test: Testing of below level sympathetic activation |
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 laboratory diagnostic testing session
Secondary outcomes (9)
Beat-to-beat heart rate
Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.
Measured: During laboratory diagnostic testing session
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: During laboratory diagnostic testing session
Continuous galvanic skin response
Changes from resting state conductance with be quantified with a smartwatch.
Measured: During laboratory diagnostic testing session
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
Respiration
Elastic respiratory transducer bands around mid-chest and upper abdomen will monitor breathing depth and frequency.
Measured: During laboratory diagnostic testing session
Beat-by-Beat Popliteal and Brachial Blood Flow
The investigators will use Doppler derived flow velocities to estimate whole limb blood flow through the popliteal and brachial arteries
Measured: During laboratory diagnostic testing session
Immunology Blood Draw
Baseline samples will be collected and compared against changes to blood pressure.
Measured: During laboratory diagnostic testing session
Serum Catecholamines and Cortisol
Baseline resting catecholamines (norepinephrine, epinephrine, dopamine) and cortisol will be drawn from the IV after 10 minutes of quiet rest at baseline and prior to bladder filling or foot cold pressor. Just prior to the conclusion of this testing, an additional blood draw will take place through the IV to assess changes in these levels.
Measured: During laboratory diagnostic testing session
Pressure-induced vasodilation
Changes to skin blood flow following a gradual change in pressure to the skin surface area. Laser doppler will be used to monitor changes in blood flow.
Measured: During laboratory diagnostic testing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start31 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- 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
- NCT07210437
- Sponsor's protocol ID
- 25-003333
- Status last verified
- Feb 2026
- First submitted
- 29 Sep 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Solinsky R, Burns K, Hamner JW, Singer W, Taylor JA. Characterizing preserved autonomic regulation following spinal cord injury: Methods of a novel concerted testing battery and illustrative examples of a new translationally focused data representation. medRxiv [Preprint]. 2024 Jun 1:2024.05.31.24308290. doi: 10.1101/2024.05.31.24308290.
PubMed 38854077
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
- Longitudinal Autonomic Characterization as a Predictor for Secondary Medical Complications Post-SCI
- ClinicalTrials.gov ID
- NCT07210437
- Acronym / sponsor ID
- 25-003333
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 7 Oct 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.
The purpose of this research is to learn about how the body is able to balance changes in blood pressure, how that changes over time, and how these changes impact a participant's risk of developing medical problems.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Spinal Cord Injury | Experimental | Diagnostic Test: Tests of sympathetic inhibition, Diagnostic Test: Tests of above level sympathetic activation, Diagnostic Test: Testing of below level sympathetic activation |
| Acute Spinal Cord Injury | Experimental | Diagnostic Test: Tests of sympathetic inhibition, Diagnostic Test: Tests of above level sympathetic activation, Diagnostic Test: Testing of below level sympathetic activation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years old
- Spinal cord injury with neurological level of injury from C6-T12
- ASIA Impairment Scale A-D.
- Either acute SCI <3 months prior (n=10) or chronic SCI (>1 year since injury, n=8).
Key exclusion criteria (4 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
- Taking or being administered a medication known to potentially have adverse interactions with phenylephrine
- In the judgement of the principal investigator, 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 | Acute Spinal Cord Injury, Chronic Spinal Cord Injury |
| Tests of above level 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 | Acute Spinal Cord Injury, Chronic Spinal Cord Injury |
| Testing of below level sympathetic activationCold pressor test of the foot and bladder pressor response will be tested. | Diagnostic test | Acute Spinal Cord Injury, Chronic Spinal Cord Injury |
Primary outcome
Valsalva Maneuver Phase II
Time frame: During laboratory diagnostic testing session
Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.
9 secondary outcomes
Beat-to-beat heart rate
Time frame: During laboratory diagnostic testing session
Beat-to-beat blood pressure
Time frame: During laboratory diagnostic testing session
Continuous galvanic skin response
Time frame: During laboratory diagnostic testing session
Quantify autonomic dysreflexia and orthostatic hypotension
Time frame: Baseline, prior to laboratory diagnostic testing session
Respiration
Time frame: During laboratory diagnostic testing session
Beat-by-Beat Popliteal and Brachial Blood Flow
Time frame: During laboratory diagnostic testing session
Immunology Blood Draw
Time frame: During laboratory diagnostic testing session
Serum Catecholamines and Cortisol
Time frame: During laboratory diagnostic testing session
Pressure-induced vasodilation
Time frame: During laboratory diagnostic testing session
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.
- Background: PubMed 38854077Solinsky R, Burns K, Hamner JW, Singer W, Taylor JA. Characterizing preserved autonomic regulation following spinal cord injury: Methods of a novel concerted testing battery and illustrative examples of a new translationally focused data representation. medRxiv [Preprint]. 2024 Jun 1:2024.05.31.24308290. doi: 10.1101/2024.05.31.24308290.
- Individual participant dataSharing planned: Undecided
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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 above level sympathetic activation and Testing of below level sympathetic activation in people with Spinal Cord Injuries, 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 4 inclusion and 4 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 laboratory diagnostic testing session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210437, which also lists 1 linked publication.
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.