Understanding Autonomic Function After Spinal Cord Injury
Deciphering Preserved Autonomic Function After Spinal Cord Injury
NA · Mayo Clinic · NCT04493372
This study is testing how spinal cord injuries affect the body's automatic functions, like blood pressure and skin responses, to help understand the specific problems people with these injuries might face.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04493372 on ClinicalTrials.gov |
What this trial studies
This study aims to characterize the dysfunction of the autonomic nervous system in individuals with spinal cord injuries compared to uninjured controls. It will involve laboratory tests to assess blood pressure regulation and other autonomic responses, utilizing multiple recordings to analyze how the body activates and inhibits signals. Participants will also wear smartwatches to track skin electrical conductance, providing additional data on autonomic function. The findings could help identify specific autonomic dysfunctions associated with spinal cord injuries.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-50 with traumatic spinal cord injuries classified as A-D on the American Spinal Injury Association Impairment Scale.
Not a fit: Patients with a history of cardiovascular disease, hypertension, or other significant neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of autonomic dysfunction in patients with spinal cord injuries.
How similar studies have performed: Other studies have explored autonomic dysfunction in spinal cord injuries, but this specific approach of using comprehensive laboratory testing and smart technology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Ryan Solinsky, MD — Mayo Clinic
- Study coordinator: PI
- Email: solinsky.ryan@mayo.edu
- Phone: 507-255-4058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries, Autonomic Imbalance, Autonomic Dysreflexia, Orthostatic Hypotension