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NIBS Therapy in Subacute Spinal Cord Injury
Sponsor: Albert Einstein Healthcare Network
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.
Official title: Noninvasive Brain Stimulation Therapy in Subacute Human Spinal Cord Injury: A Translational Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-04-09
Completion Date
2026-05-31
Last Updated
2025-04-30
Healthy Volunteers
No
Interventions
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.
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
Locations (1)
Jefferson Moss-Magee Rehabilitation - Elkins Park
Elkins Park, Pennsylvania, United States