NIBS Therapy in Subacute Spinal Cord Injury

Part of paid clinical trials in Elkins Park, Pennsylvania.

Sponsor
Albert Einstein Healthcare Network
Study ID
NCT06247904
Status
Enrolling By Invitation

Conditions

  • Tetraplegia/Tetraparesis
  • Traumatic Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Active rTMS — DEVICE
    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 — DEVICE
    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

Study Details

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.

Key Dates

Start date
Apr 9, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
May 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active rTMS
    10 daily sessions of High-frequency Transcranial Magnetic Stimulation (HF-rTMS) applied bilaterally over the hand primary motor area informed by e-field modelling and targeting will be aided by neuronavigation system for precise targeting during each intervention session. Active group will receive HF-rTMS intensity calculated using electric field modelling to create electric field intensity of approximately motor threshold, using the cool-B65 A/P rTMS coil.
  • Sham Comparator: Sham rTMS
    10 daily sessions of Sham High-frequency Transcranial Magnetic Stimulation (HF-rTMS) applied bilaterally over the hand primary motor area informed by e-field modelling and targeting will be aided by neuronavigational system for precise targeting during each intervention session Sham group receives no active magnetic stimulation. Cool-B65 A/P rTMS coil will be used to avoid unblinding of administrator and/or study participant.

Primary Outcome Measure

Eligibility - (Percentage candidates eligible of screened patients) [ Time Frame: 21 months (Recruitment period) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Jefferson Moss-Magee Rehabilitation - Elkins ParkElkins ParkPennsylvania19027-

Find similar trials in Elkins Park, PA

By research site
Jefferson Moss-Magee Rehabilitation - Elkins Park· Elkins Park, PA

Related Studies