Spinal Cord InjuriesNCT07210411
Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
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 participant's body is able to balance changes in blood pressure, and how spinal cord stimulation affects these changes as well as immune \& cardiovascular function in participants with spinal cord injury. 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
- 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, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2026to 1 Apr 2031
- 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
- Age 18-50.
- American Spinal Injury Association Impairment Scale A-D,64 to encompass a representational spectrum of autonomic dysfunction after spinal cord injury.
- Neurological level of injury, C6-T8, as defined by the International Standards for Neurological Classification of Spinal Cord Injury.64 Incorporating level of injury over this broad range to capture the spectrum of autonomic dysfunction. Individuals with injuries below T8 will not be included to ensure transcutaneous spinal cord stimulation does not occur over the injury/glial scar, where it may have altered properties. The C6 level was chosen to ensure hand cold pressor stimuli triggers above level sympathetic activation.
- Time since injury of greater than six months, given early changes in spinal cord connectivity and recovery prior to this.
- Both individuals with and without currently implanted epidural spinal cord stimulators will be enrolled.
- Twenty uninjured controls will also be enrolled.
Who cannot join
- History of clinically diagnosed cardiovascular disease, diabetes, autonomic neuropathies, neurological disorders (with exception of spinal cord injury for individuals in those cohorts), or are active smokers.
- Individuals who are taking betablockers, antihypertensives, or other sympathetically active medications which they are unable to hold.
- Women who are pregnant or lactating, given known hormonal influences on autonomic regulation.65,66
- Cognitive issues preventing informed consent for participation.
- Body mass index >30 kg/m2 for the uninjured controls only given increased risk of prediabetes and potential confounding normative values.
- 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 participant's body is able to balance changes in blood pressure, and how spinal cord stimulation affects these changes as well as immune \& cardiovascular function in participants with spinal cord injury.
- Conditions
- Spinal Cord Injuries
- Being tested
- Tests of sympathetic inhibition, Tests of above level sympathetic activation, Testing of below level sympathetic activation, Epidural stimulation, Transcutaneous stimulation
- 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 (in individuals with SCI) will be tested.
Epidural stimulationDevice
Currently implanted epidural stimulation will be used during diagnostic testing.
Transcutaneous stimulationDevice
Transcutaneous stimulation will be used for participants with spinal cord injury without an implanted stimulator during diagnostic testing.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Control participants without a spinal cord injury Receives: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of above level sympathetic activation; Diagnostic Test: Testing of below level sympathetic activation |
| Transcutaneous stimulation | Experimental | Individuals with spinal cord injury receiving transcutaneous stimulation Receives: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of above level sympathetic activation; Diagnostic Test: Testing of below level sympathetic activation; Device: Transcutaneous stimulation |
| Epidural stimulation | Experimental | Individuals with spinal cord injury receiving epidural stimulation Receives: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of above level sympathetic activation; Diagnostic Test: Testing of below level sympathetic activation; Device: Epidural stimulation |
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 (8)
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
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 start5 Mar 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 80 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
- NCT07210411
- Sponsor's protocol ID
- 25-001000
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Solinsky R, Burns K, Tuthill C, Hamner JW, Taylor JA. Transcutaneous spinal cord stimulation and its impact on cardiovascular autonomic regulation after spinal cord injury. Am J Physiol Heart Circ Physiol. 2024 Jan 1;326(1):H116-H122. doi: 10.1152/ajpheart.00588.2023. Epub 2023 Nov 10.
PubMed 37947438Solinsky R, Burns K, Hamner JW, Veith DD, Singer W, Taylor JA. A Novel Testing Battery for Preserved Autonomic Regulation Following Spinal Cord Injury and New Translationally Focused Data Representation. Top Spinal Cord Inj Rehabil. 2025 Spring;31(2):50-61. doi: 10.46292/sci24-00071. Epub 2025 Jun 19.
PubMed 40585014
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
- Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07210411
- Acronym / sponsor ID
- 25-001000
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 1 Apr 2031 (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 participant's body is able to balance changes in blood pressure, and how spinal cord stimulation affects these changes as well as immune \& cardiovascular function in participants with spinal cord injury.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Diagnostic Test: Tests of sympathetic inhibition, Diagnostic Test: Tests of above level sympathetic activation, Diagnostic Test: Testing of below level sympathetic activationControl participants without a spinal cord injury |
| Transcutaneous stimulation | Experimental | Diagnostic Test: Tests of sympathetic inhibition, Diagnostic Test: Tests of above level sympathetic activation, Diagnostic Test: Testing of below level sympathetic activation, Device: Transcutaneous stimulationIndividuals with spinal cord injury receiving transcutaneous stimulation |
| Epidural stimulation | Experimental | Diagnostic Test: Tests of sympathetic inhibition, Diagnostic Test: Tests of above level sympathetic activation, Diagnostic Test: Testing of below level sympathetic activation, Device: Epidural stimulationIndividuals with spinal cord injury receiving epidural stimulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-50.
- American Spinal Injury Association Impairment Scale A-D,64 to encompass a representational spectrum of autonomic dysfunction after spinal cord injury.
- Neurological level of injury, C6-T8, as defined by the International Standards for Neurological Classification of Spinal Cord Injury.64 Incorporating level of injury over this broad range to capture the spectrum of autonomic dysfunction. Individuals with injuries below T8 will not be included to ensure transcutaneous spinal cord stimulation does not occur over the injury/glial scar, where it may have altered properties. The C6 level was chosen to ensure hand cold pressor stimuli triggers above level sympathetic activation.
- Time since injury of greater than six months, given early changes in spinal cord connectivity and recovery prior to this.
- Both individuals with and without currently implanted epidural spinal cord stimulators will be enrolled.
Key exclusion criteria (7 listed)
- History of clinically diagnosed cardiovascular disease, diabetes, autonomic neuropathies, neurological disorders (with exception of spinal cord injury for individuals in those cohorts), or are active smokers.
- Individuals who are taking betablockers, antihypertensives, or other sympathetically active medications which they are unable to hold.
- Women who are pregnant or lactating, given known hormonal influences on autonomic regulation.65,66
- Cognitive issues preventing informed consent for participation.
- Body mass index >30 kg/m2 for the uninjured controls only given increased risk of prediabetes and potential confounding normative values.
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 | Control, Epidural stimulation, Transcutaneous stimulation |
| 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 | Control, Epidural stimulation, Transcutaneous stimulation |
| Testing of below level sympathetic activationCold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested. | Diagnostic test | Control, Epidural stimulation, Transcutaneous stimulation |
| Epidural stimulationCurrently implanted epidural stimulation will be used during diagnostic testing. | Device | Epidural stimulation |
| Transcutaneous stimulationTranscutaneous stimulation will be used for participants with spinal cord injury without an implanted stimulator during diagnostic testing. | Device | Transcutaneous stimulation |
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.
8 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
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 37947438Solinsky R, Burns K, Tuthill C, Hamner JW, Taylor JA. Transcutaneous spinal cord stimulation and its impact on cardiovascular autonomic regulation after spinal cord injury. Am J Physiol Heart Circ Physiol. 2024 Jan 1;326(1):H116-H122. doi: 10.1152/ajpheart.00588.2023. Epub 2023 Nov 10.
- Background: PubMed 40585014Solinsky R, Burns K, Hamner JW, Veith DD, Singer W, Taylor JA. A Novel Testing Battery for Preserved Autonomic Regulation Following Spinal Cord Injury and New Translationally Focused Data Representation. Top Spinal Cord Inj Rehabil. 2025 Spring;31(2):50-61. doi: 10.46292/sci24-00071. Epub 2025 Jun 19.
- 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 6 inclusion and 7 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 NCT07210411, which also lists 2 linked publications.
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.