RECRUITING

Deciphering Preserved Autonomic Function After Spinal Cord Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Deciphering Preserved Autonomic Function After Spinal Cord Injury

Quick Facts

Study Start:2020-11-13
Study Completion:2025-06-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04493372

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult onset, traumatic spinal cord injury.
  2. * American Spinal Injury Association Impairment Scale, A-D, to encompass a spectrum of autonomic dysfunction after spinal cord injury.
  3. * 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.
  1. * History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes.
  2. * Women who are pregnant or lactating.
  3. * Currently taking blood thinners.
  4. * Pacemaker, implanted defibrillator, or intrathecal pump incompatible with MRI scanning.
  5. * Cognitive issues preventing informed consent for participation.
  6. * 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.

Contacts and Locations

Study Contact

PI
CONTACT
507-255-4058
solinsky.ryan@mayo.edu

Principal Investigator

Ryan Solinsky, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55902
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Ryan Solinsky, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-13
Study Completion Date2025-06-28

Study Record Updates

Study Start Date2020-11-13
Study Completion Date2025-06-28

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Autonomic Imbalance
  • Autonomic Dysreflexia
  • Orthostatic Hypotension