Longitudinal Autonomic Characterization as a Predictor for Secondary Medical Complications Post-SCI

Purpose

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.

Condition

  • Spinal Cord Injuries

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Chronic Spinal Cord Injury
  • 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 will be tested.
Experimental
Acute Spinal Cord Injury
  • 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 will be tested.

Recruiting Locations

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
Contact:
Zachary Pohlkamp
507-422-0140

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Zachary Pohlkamp
507-422-0140
pohlkamp.zachary@mayo.edu