Spinal Cord InjuriesNCT04493372
Deciphering Preserved Autonomic Function After Spinal Cord Injury
A study testing Tests of sympathetic inhibition, Tests of sympathetic activation and Testing of autonomic dysreflexia in people with Spinal Cord Injuries and Autonomic Imbalance, 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 after spinal cord injury. The autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury typically suffer. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Autonomic Imbalance, 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
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2020to 8 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All subjects
- age 18-50 years old.
- Participants with spinal cord injury
- Adult onset, traumatic spinal cord injury.
- American Spinal Injury Association Impairment Scale, A-D, to encompass a spectrum of autonomic dysfunction after spinal cord injury.
- Neurological level of injury, C1-T12, as defined by the International Standards for Neurological Classification of Spinal Cord Injury. Incorporating level of injury down to T12 to encompass a broad range of autonomic dysfunction.
Who cannot join
- History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes.
- Women who are pregnant or lactating.
- Currently taking blood thinners.
- Pacemaker, implanted defibrillator, or intrathecal pump incompatible with MRI scanning.
- Cognitive issues preventing informed consent for participation.
- Body mass index >30 kg/m2 for controls, in an effort to limit effects of early cardiovascular disease and diabetes in control population. Body mass index has not proven to be a good estimate of these factors following spinal cord injury.
Trial locations and contacts
1 site in 1 country.
About this study
This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. The autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury 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 spinal cord injury 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 after spinal cord injury will exhibit abnormalities in these precise metrics. The investigators will further have research participants wear a smart watch that tracks skin electrical conductance, heart rate, and skin temperature, which can all provide clues as to the degree of autonomic dysfunction someone may suffer at home. The investigators will look to see if any substantial connections exist between different degrees of preserved autonomic function and secondary autonomic complications from spinal cord injury. In accomplishing this, the investigators hope to give scientists important insights to how the autonomic nervous system works after spinal cord injury and give physicians better tools to manage these secondary autonomic complications.
Read the detailed description
This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. To accomplish this, we are enrolling both individuals with and without spinal cord injuries (see inclusion criteria). Individuals will undergo the listed diagnostics as part of a battery of laboratory testing. These will be correlated to clinical histories of autonomic dysfunction the Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI) and COMPASS-31 surveys (noted in outcome measures).
- Being tested
- Tests of sympathetic inhibition, Tests of sympathetic activation, Testing of autonomic dysreflexia
- Medical subject headings
- Spinal Cord Injuries, Autonomic Dysreflexia, Hypotension, Orthostatic
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 (in individuals with SCI) will be tested.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with spinal cord injury | Experimental | Not described Receives: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of sympathetic activation; Diagnostic Test: Testing of autonomic dysreflexia |
| Individuals without spinal cord injury | 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 laboratory diagnostic testing session
Secondary outcomes (6)
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
Continuous wrist temperature
Changes from resting state temperature 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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start13 Nov 2020
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Ryan J. Solinsky, Mayo Clinic
- Investigators
- Ryan Solinsky, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493372
- Sponsor's protocol ID
- 23-005772
- Other IDs
- 5K23HD102663-05
- Status last verified
- Apr 2026
- First submitted
- 17 Jul 2020
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering Preserved Autonomic Function After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04493372
- Acronym / sponsor ID
- 23-005772
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 30 Jul 2020 (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 after spinal cord injury. The autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury 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 spinal cord injury 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 after spinal cord injury will exhibit abnormalities in these precise metrics. The investigators will further have research participants wear a smart watch that tracks skin electrical conductance, heart rate, and skin temperature, which can all provide clues as to the degree of autonomic dysfunction someone may suffer at home. The investigators will look to see if any substantial connections exist between different degrees of preserved autonomic function and secondary autonomic complications from spinal cord injury. In accomplishing this, the investigators hope to give scientists important insights to how the autonomic nervous system works after spinal cord injury and give physicians better tools to manage these secondary autonomic complications.
Detailed description
This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. To accomplish this, we are enrolling both individuals with and without spinal cord injuries (see inclusion criteria). Individuals will undergo the listed diagnostics as part of a battery of laboratory testing. These will be correlated to clinical histories of autonomic dysfunction the Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI) and COMPASS-31 surveys (noted in outcome measures).
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 spinal cord injury | Experimental | Diagnostic Test: Tests of sympathetic inhibition, Diagnostic Test: Tests of sympathetic activation, Diagnostic Test: Testing of autonomic dysreflexia |
| Individuals without spinal cord injury | 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 (6 listed)
- All subjects
- age 18-50 years old.
- Participants with spinal cord injury
- Adult onset, traumatic spinal cord injury.
- American Spinal Injury Association Impairment Scale, A-D, to encompass a spectrum of autonomic dysfunction after spinal cord injury.
Key exclusion criteria (6 listed)
- History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes.
- Women who are pregnant or lactating.
- Currently taking blood thinners.
- Pacemaker, implanted defibrillator, or intrathecal pump incompatible with MRI scanning.
- Cognitive issues preventing informed consent for participation.
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 spinal cord injury, Individuals without spinal cord injury |
| 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 spinal cord injury, Individuals without spinal cord injury |
| Testing of autonomic dysreflexiaCold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested. | Diagnostic test | Individuals with spinal cord injury, Individuals without 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.
6 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
Continuous wrist temperature
Time frame: During laboratory diagnostic testing session
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 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. This study is not recruiting at the moment.
Ryan 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 Spinal Cord Injuries and Autonomic Imbalance, 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 16 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
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 16 Sep 2026.