Deciphering Preserved Autonomic Function After Spinal Cord Injury

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed Show 6 more changesShow less
    • Final enrollment: 62 participants (planned 69)
    • Primary completion date changed from estimate of Sep 8, 2026 to Jun 8, 2026
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 6 words
    • Site details revised
    • Collaborators expanded, about 12 words
  2. Minor Site contact updatedv11
  3. Minor Primary and study completion pushed from Mar 31, 2026 to Sep 8, 2026v10
  4. Minor Primary and study completion dates: Dec 31, 2025 to Mar 31, 2026v9
  5. Minor Primary and study completion dates: Jul 30, 2025 to Dec 31, 2025v8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Primary and study completion dates pushed to Jul 30, 2025v7
  2. Notable Trial status: Suspended to Recruiting
    • Primary completion date: Dec 1, 2024 to May 30, 2025
    • Study completion date: Dec 1, 2024 to Jun 28, 2025
    • Site details revised
    v6
  3. Stopped Trial status: Recruiting to Suspended Sponsor's reason: Transfer of institutionsv5 Show 6 more changesShow less
    • Lead sponsor: Spaulding Rehabilitation Hospital to Mayo Clinic
    • Primary and study completion dates: Aug 1, 2024 to Dec 1, 2024
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 8 to 6
    • Study description shortened, about 12 words
    • Study site revised
  4. Minor Study description expanded, about 79 wordsv4
  5. Minor Eligibility criteria expanded, about 40 wordsv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 1, 2020 to Nov 13, 2020
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT04493372
Lead Sponsor Mayo Clinic
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Spinal Cord Injuries, Autonomic Imbalance, Autonomic Dysreflexia, Orthostatic Hypotension
Related terms Autonomic Dysreflexia, Hypotension, Orthostatic, Spinal Cord Injuries
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov