Spinal Cord Injuries Clinical Trial
Official title:
Deciphering Preserved Autonomic Function After Spinal Cord Injury
Verified date | June 2024 |
Source | Mayo Clinic |
Contact | PI |
Phone | 507-255-4058 |
solinsky.ryan[@]mayo.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 69 |
Est. completion date | June 28, 2025 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Beat-to-beat heart rate | Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline. | During laboratory diagnostic testing session | |
Secondary | Beat-to-beat blood pressure | Non-invasive continuous blood pressure monitors will be used, with changes in systolic and diastolic pressure (in mmHg) from resting baseline measured. | During laboratory diagnostic testing session | |
Secondary | Continuous galvanic skin response | Changes from resting state conductance with be quantified with a smartwatch. | During laboratory diagnostic testing session | |
Secondary | Continuous wrist temperature | Changes from resting state temperature with be quantified with a smartwatch. | During laboratory diagnostic testing session | |
Secondary | Quantify autonomic dysreflexia and orthostatic hypotension | Participants will be given the Autonomic Dysfunction Following Spinal Cord Injury questionnaire (score range 0-436, with higher scores indicating more autonomic dysfunction). | Baseline, prior to laboratory diagnostic testing session | |
Secondary | Quantify secondary autonomic complications | Participants will be given the Composite Autonomic Symptom Score (range 0-100, with higher scores indicating more autonomic dysfunction). | Baseline, prior to laboratory diagnostic testing session |
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