Deciphering Preserved Autonomic Function After Spinal Cord Injury

Not Applicable

Recruiting

• Conditions: Autonomic Dysreflexia; Orthostatic Hypotension; Spinal Cord Injuries; Autonomic Imbalance
• Interventions: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of sympathetic activation; Diagnostic Test: Testing of autonomic dysreflexia

• Registration Number: NCT04493372
• Lead Sponsor: Mayo Clinic

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-30
• Study Start: 2020-11-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 69

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individuals with spinal cord injury	Testing of autonomic dysreflexia	-
Individuals with spinal cord injury	Tests of sympathetic inhibition	-
Individuals with spinal cord injury	Tests of sympathetic activation	-
Individuals without spinal cord injury	Testing of autonomic dysreflexia	-
Individuals without spinal cord injury	Tests of sympathetic inhibition	-
Individuals without spinal cord injury	Tests of sympathetic activation	-

Primary Outcome Measures

Name	Time	Method
Valsalva Maneuver Phase II	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 Outcome Measures

Name	Time	Method
Continuous wrist temperature	During laboratory diagnostic testing session	Changes from resting state temperature with be quantified with a smartwatch.
Beat-to-beat blood pressure	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.
Continuous galvanic skin response	During laboratory diagnostic testing session	Changes from resting state conductance with be quantified with a smartwatch.
Quantify secondary autonomic complications	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).
Beat-to-beat heart rate	During laboratory diagnostic testing session	Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.
Quantify autonomic dysreflexia and orthostatic hypotension	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).

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States