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NIBS Therapy in Subacute Spinal Cord Injury

Study acronym: NIBS-SCI1
StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record status
This record was last updated April 30, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Apr 15, 2024 to Apr 9, 2025
    • Study completion date: Dec 31, 2025 to May 31, 2026
    • Eligibility criteria expanded, about 2 words
    v3
  2. Primary endpoints revised (6)
    • Secondary endpoints revised (3)
    • Collaborators: 4 to 6
    • Eligibility criteria shortened, about 2 words
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
No accepted clinical therapies exist for repair of motor pathways following spinal cord injury (SCI) in humans, leaving permanent disability and devastating personal and socioeconomic cost. A robust neural repair strategy has been demonstrated in preclinical studies, that is ready for translation to recovery of hand and arm function in human SCI, comprising daily transcranial magnetic stimulation treatment at the inpatient rehabilitation facility. This study will establish clinical effect size of the intervention, as well as safety and feasibility necessary for a subsequent controlled efficacy trial and inform preclinical studies for dosing optimization.
Trial Details
NCT Number NCT06247904
Lead Sponsor Albert Einstein Healthcare Network
Collaborators: Pennsylvania Department of Health, University of Mississippi Medical Center, University of Sao Paulo, Massachusetts General Hospital, Weill Medical College of Cornell University, Burke Medical Research Institute
Conditions
(from sponsor)		 Traumatic Spinal Cord Injury, Tetraplegia/Tetraparesis
Related terms Quadriplegia, Spinal Cord Injuries
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov