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NCT Number: NCT04493372

Deciphering Preserved Autonomic Function After Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Autonomic Dysreflexia Autonomic Imbalance Autonomic Nervous System Diseases Cardiovascular Diseases Central Nervous System Diseases Hypotension Hypotension, Orthostatic Nervous System Diseases Orthostatic Hypotension Orthostatic Intolerance Primary Dysautonomias Spinal Cord Diseases Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location status: Recruiting

Location contact

Erin Lund

CONTACT

[email protected]

507-284-9298

About this study

This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. To accomplish this, we are enrolling both individuals with and without spinal cord injuries (see inclusion criteria). Individuals will undergo the listed diagnostics as part of a battery of laboratory testing. These will be correlated to clinical histories of autonomic dysfunction the ADFSCI and COMPASS-31 surveys (noted in outcome measures).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

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 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 autonomic dysreflexia

Diagnostic Test

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

Primary outcomes

  1. Valsalva Maneuver Phase II

    Time frame: During laboratory diagnostic testing session

    Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.

Secondary outcomes

  1. Beat-to-beat heart rate

    Time frame: During laboratory diagnostic testing session

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

  2. Beat-to-beat blood pressure

    Time frame: During laboratory diagnostic testing session

    Non-invasive continuous blood pressure monitors will be used, with changes in systolic and diastolic pressure (in mmHg) from resting baseline measured.

  3. Continuous galvanic skin response

    Time frame: During laboratory diagnostic testing session

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

  4. Continuous wrist temperature

    Time frame: During laboratory diagnostic testing session

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

  5. Quantify autonomic dysreflexia and orthostatic hypotension

    Time frame: Baseline, prior to laboratory diagnostic testing session

    Participants will be given the Autonomic Dysfunction Following Spinal Cord Injury questionnaire (score range 0-436, with higher scores indicating more autonomic dysfunction).

  6. Quantify secondary autonomic complications

    Time frame: Baseline, prior to laboratory diagnostic testing session

    Participants will be given the Composite Autonomic Symptom Score (range 0-100, with higher scores indicating more autonomic dysfunction).

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Lund

CONTACT

[email protected]

507-284-9298

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2020
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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