Deciphering Preserved Autonomic Function After Spinal Cord Injury
1 other identifier
interventional
69
1 country
1
Brief Summary
This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. The autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury typically suffer. Focusing on blood pressure regulation, the most precise metric with broad clinical applicability, the investigators will perform laboratory-based tests to probe the body's ability to generate autonomic responses. For both individuals with spinal cord injury and uninjured controls, laboratory-based experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate signals. The investigators anticipate that those with autonomic dysfunction after spinal cord injury will exhibit abnormalities in these precise metrics. The investigators will further have research participants wear a smart watch that tracks skin electrical conductance, heart rate, and skin temperature, which can all provide clues as to the degree of autonomic dysfunction someone may suffer at home. The investigators will look to see if any substantial connections exist between different degrees of preserved autonomic function and secondary autonomic complications from spinal cord injury. In accomplishing this, the investigators hope to give scientists important insights to how the autonomic nervous system works after spinal cord injury and give physicians better tools to manage these secondary autonomic complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedStudy Start
First participant enrolled
November 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 8, 2026
May 1, 2026
April 1, 2026
5.8 years
July 17, 2020
April 27, 2026
Conditions
Outcome Measures
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.
During laboratory diagnostic testing session
Secondary Outcomes (6)
Beat-to-beat heart rate
During laboratory diagnostic testing session
Beat-to-beat blood pressure
During laboratory diagnostic testing session
Continuous galvanic skin response
During laboratory diagnostic testing session
Continuous wrist temperature
During laboratory diagnostic testing session
Quantify autonomic dysreflexia and orthostatic hypotension
Baseline, prior to laboratory diagnostic testing session
- +1 more secondary outcomes
Study Arms (2)
Individuals with spinal cord injury
EXPERIMENTALIndividuals without spinal cord injury
EXPERIMENTALInterventions
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.
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).
Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
Eligibility Criteria
You may qualify if:
- All subjects
- \- age 18-50 years old.
- Participants with spinal cord injury
- Adult onset, traumatic spinal cord injury.
- American Spinal Injury Association Impairment Scale, A-D, to encompass a spectrum of autonomic dysfunction after spinal cord injury.
- Neurological level of injury, C1-T12, as defined by the International Standards for Neurological Classification of Spinal Cord Injury. Incorporating level of injury down to T12 to encompass a broad range of autonomic dysfunction.
You may not qualify if:
- History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes.
- Women who are pregnant or lactating.
- Currently taking blood thinners.
- Pacemaker, implanted defibrillator, or intrathecal pump incompatible with MRI scanning.
- Cognitive issues preventing informed consent for participation.
- Body mass index \>30 kg/m2 for controls, in an effort to limit effects of early cardiovascular disease and diabetes in control population. Body mass index has not proven to be a good estimate of these factors following spinal cord injury.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55902, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Solinsky, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 17, 2020
First Posted
July 30, 2020
Study Start
November 13, 2020
Primary Completion (Estimated)
September 8, 2026
Study Completion (Estimated)
September 8, 2026
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share