Health TrialsbyHealthPanel

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

ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tests of sympathetic inhibition

    Diagnostic 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 activation

    Diagnostic 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 activation

    Diagnostic test

    Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.

  • Epidural stimulation

    Device

    Currently implanted epidural stimulation will be used during diagnostic testing.

  • Transcutaneous stimulation

    Device

    Transcutaneous stimulation will be used for participants with spinal cord injury without an implanted stimulator during diagnostic testing.

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: ControlExperimental treatment 3 interventions
Group B: Transcutaneous stimulationExperimental treatment 4 interventions
Group C: Epidural stimulationExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
During laboratory diagnostic testing session

Secondary outcomes

1

Beat-to-beat heart rate

Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.

Time frame
During laboratory diagnostic testing session
2

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.

Time frame
During laboratory diagnostic testing session
3

Continuous galvanic skin response

Changes from resting state conductance with be quantified with a smartwatch.

Time frame
During laboratory diagnostic testing session
4

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).

Time frame
Baseline, prior to laboratory diagnostic testing session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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