Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
NCT ID: NCT07210411
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2026-02-01
2031-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Control
Control participants without a spinal cord injury
Tests 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.
Tests of above level 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).
Testing of below level sympathetic activation
Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
Transcutaneous stimulation
Individuals with spinal cord injury receiving transcutaneous stimulation
Tests 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.
Tests of above level 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).
Testing of below level sympathetic activation
Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
Transcutaneous stimulation
Transcutaneous stimulation will be used for participants with spinal cord injury without an implanted stimulator during diagnostic testing.
Epidural stimulation
Individuals with spinal cord injury receiving epidural stimulation
Tests 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.
Tests of above level 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).
Testing of below level sympathetic activation
Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
Epidural stimulation
Currently implanted epidural stimulation will be used during diagnostic testing.
Interventions
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Tests 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.
Tests of above level 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).
Testing of below level sympathetic activation
Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
Epidural stimulation
Currently implanted epidural stimulation will be used during diagnostic testing.
Transcutaneous stimulation
Transcutaneous stimulation will be used for participants with spinal cord injury without an implanted stimulator during diagnostic testing.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Ryan J. Solinsky
Principal Investigator
Principal Investigators
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Ryan Solinsky, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Zachary Pohlkamp
Role: primary
References
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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.
Solinsky 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.
Other Identifiers
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25-001000
Identifier Type: -
Identifier Source: org_study_id
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