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NIBS Therapy in Subacute Spinal Cord Injury

NCT06247904 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Traumatic Spinal Cord Injury
  • Tetraplegia/Tetraparesis

Interventions

DEVICE

Active rTMS

The stimulation protocol will comprise 15Hz pulse trains, each 50 pulses, repeated 10x, with a 60s inter-train interval. Stimulation intensity will be determined from individual MRI-modeled e-field, to achieve approximately motor threshold in the target area.

DEVICE

sham rTMS

The stimulation protocol will comprise 15Hz pulse trains, each 50 pulses, repeated 10x, with a 60s inter-train interval. Stimulation intensity will be close to zero (negligible) since sham coil will be used for the intervention

Sponsors & Collaborators

  • Pennsylvania Department of Health

    collaborator OTHER_GOV

  • University of Mississippi Medical Center

    collaborator OTHER

  • University of Sao Paulo

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Burke Medical Research Institute

    collaborator OTHER

  • Albert Einstein Healthcare Network

    lead OTHER

Principal Investigators

  • Dylan J Edwards, PhD · Albert Einstein Healthcare Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-09
Primary Completion
2025-12-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06247904 on ClinicalTrials.gov