Clinical trial NCT04493372: Deciphering Preserved Autonomic Function After Spinal Cord Injury
Official title: Deciphering Preserved Autonomic Function After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Autonomic Imbalance
Autonomic Dysreflexia
Orthostatic Hypotension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Valsalva Maneuver Phase II
timeFrame: During laboratory diagnostic testing session
Secondary outcomes:
measure: Beat-to-beat heart rate
timeFrame: During laboratory diagnostic testing session
measure: Beat-to-beat blood pressure
timeFrame: During laboratory diagnostic testing session
measure: Continuous galvanic skin response
timeFrame: During laboratory diagnostic testing session
measure: Continuous wrist temperature
timeFrame: During laboratory diagnostic testing session
measure: Quantify autonomic dysreflexia and orthostatic hypotension
timeFrame: Baseline, prior to laboratory diagnostic testing session
measure: Quantify secondary autonomic complications
timeFrame: Baseline, prior to laboratory diagnostic testing session
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ryan Solinsky, MD
role: PRINCIPAL_INVESTIGATOR
References: