Longitudinal Autonomic Characterization as a Predictor for Secondary Medical Complications Post-SCI
ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMayo Clinic
About this trial
The purpose of this research is to learn about how the body is able to balance changes in blood pressure, how that changes over time, and how these changes impact a participant's risk of developing medical problems.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-75 years old
Spinal cord injury with neurological level of injury from C6-T12
ASIA Impairment Scale A-D.
Either acute SCI <3 months prior (n=10) or chronic SCI (>1 year since injury, n=8).
Disqualifiers
Symptoms of cardiovascular (including, but not limited to: hypertension, stroke, chest pain, etc.), respiratory, peripheral neurological or autonomic disease (particularly diabetes mellitus requiring treatment);
Women who are pregnant or lactating
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 design
Design model
Parallel
Treatments tested in this trial
Tests of sympathetic inhibition
Diagnostic testBolus 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 testCold 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 testCold pressor test of the foot and bladder pressor response will be tested.
Treatment groups
18 Participants
are divided into 2 treatment groupsGroup A: Chronic Spinal Cord InjuryExperimental treatment 3 interventions
Group B: Acute Spinal Cord InjuryExperimental treatment 3 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 sessionSecondary 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 session2
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 session3
Continuous galvanic skin response
Changes from resting state conductance with be quantified with a smartwatch.
Time frame
During laboratory diagnostic testing session4
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 sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
The Craig H. Neilsen Foundation
Collaborator
Source ClinicalTrials.gov