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Recruiting NCT07210411

Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury

No phase Interventional Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tests of sympathetic inhibition, Tests of above level sympathetic activation, Testing of below level sympathetic activation, Epidural stimulation.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test 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.
  • Diagnostic test 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).
  • Diagnostic test Testing of below level sympathetic activation
    Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
  • Device Epidural stimulation
    Currently implanted epidural stimulation will be used during diagnostic testing.
  • Device Transcutaneous stimulation
    Transcutaneous stimulation will be used for participants with spinal cord injury without an implanted stimulator during diagnostic testing.

Primary outcome measures

  • Valsalva Maneuver Phase II [Time frame: During laboratory diagnostic testing session]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

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. PMID 37947438
  • 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. PMID 40585014

Identifiers

NCT: NCT07210411 · 25-001000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗