Deciphering Preserved Autonomic Function After Spinal Cord Injury

Last updated: June 11, 2024
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthostatic Hypotension

Dizzy/fainting Spells

Circulation Disorders

Treatment

Tests of sympathetic inhibition

Tests of sympathetic activation

Testing of autonomic dysreflexia

Clinical Study ID

NCT04493372
23-005772
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 ofautonomic dysfunction after spinal cord injury.

  • Neurological level of injury, C1-T12, as defined by the International Standards forNeurological Classification of Spinal Cord Injury. Incorporating level of injurydown to T12 to encompass a broad range of autonomic dysfunction.

Exclusion

Exclusion Criteria:

  • History of cardiovascular disease, hypertension, neurologic disorders (withexception of spinal cord injury), or diabetes.

  • Women who are pregnant or lactating.

  • Currently taking blood thinners.

  • Pacemaker, implanted defibrillator, or intrathecal pump incompatible with MRIscanning.

  • Cognitive issues preventing informed consent for participation.

  • Body mass index >30 kg/m2 for controls, in an effort to limit effects of earlycardiovascular disease and diabetes in control population. Body mass index has notproven to be a good estimate of these factors following spinal cord injury.

Study Design

Total Participants: 69
Treatment Group(s): 3
Primary Treatment: Tests of sympathetic inhibition
Phase:
Study Start date:
November 13, 2020
Estimated Completion Date:
June 28, 2025

Study Description

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).

Connect with a study center

  • Spaulding Rehabilitation Hospital

    Boston, Massachusetts 02129
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Active - Recruiting

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