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Transformation of Paralysis to Stepping

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Interventions: Body Weight Supported Treadmill Training (Device), Buspirone (Drug), Ekso Bionics Exoskeleton (Device), Gravity Neutral Device (Device)… to Body Weight Supported Treadmill Training (Device), Buspirone (Drug), Gravity Neutral Device (Device), Non-invasive Spinal Cord Stimulation…
    • Study description expanded, about 2 words
    v12
  2. Eligibility criteria shortened, about 87 words
    • Collaborators revised (2)
    v11
  3. Re-verified, no change to tracked fieldsv10
  4. Primary completion date: Aug 31, 2024 to Aug 31, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Collaborators: 1 to 2
    v9
  5. 2 versions Re-verified since Feb 13, 2023, no change to tracked fieldsv7-v8
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  1. Site contact updatedv6
  2. Re-verified, no change to tracked fieldsv5
  3. Collaborators expanded, about 8 wordsv4
  4. Site contact updatedv3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Dec 1, 2024 to Aug 31, 2024
    • Study completion date: Jan 15, 2025 to Dec 31, 2027
    • Start date changed from estimate of Dec 1, 2019 to Sep 30, 2019
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main goal of the project is to develop multiple noninvasive neuromodulatory strategies to facilitate full weight bearing stepping overground in people with paralysis. We will determine the effectiveness of combining noninvasive spinal cord stimulation and the administration of buspirone (a monoaminergic agonist) in facilitating locomotor activity in a gravity-neutral apparatus, during body weight supported stepping on a treadmill, when stepping overground, or during full weight bearing stepping overground in a rolling walker. Our objective is to identify the experimental variables that define the efficacy of these novel neuromodulatory techniques over a 5 year period in 15 participants with severe spinal cord injury who are at least one year post-injury.
Trial Details
NCT Number NCT04105114
Lead Sponsor University of Louisville
Collaborators: National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 Spinal Cord Injuries
Related terms Paralysis, Spinal Cord Injuries
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov