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
Qualifiers
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
Treatments tested in this trial
- Tests of sympathetic inhibition
- Tests of above level sympathetic activation
- Testing of below level sympathetic activation
Treatment groups
18 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mayo Clinic
Lead sponsor
The Craig H. Neilsen Foundation
Collaborator
Source ClinicalTrials.gov