Transcutaneous Spinal Stimulation: Safety and Feasibility for Upper Limb Function in Children With Spinal Cord Injury

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT04032990
Status
Recruiting
Apply to this trial

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

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

Interventions

  • Biostim-5 transcutaneous spinal stimulator — DEVICE
    Safety and feasibility will be monitored during transcutaneous spinal stimulation in children with spinal cord injury

Study Details

Children who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. The purpose of this project is to test the safety, comfort, and practicality of a new therapy that stimulates the spinal cord to facilitate activation of arm and hand muscles while practicing grasping, pinching, and reaching movements. The long-term goal is to provide better therapies that will improve the ability of children with SCI to more successfully play and accomplish everyday tasks using their arms and hands, similar to before their injury.

Key Dates

Start date
Nov 14, 2019
Status verified
Jun 2024
Primary completion
Feb 28, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Transcutaneous spinal stimulation - Acute and Training
    Safety and feasibility outcome measures are collected during application of transcutaneous spinal stimulation while upper extremity function is assessed at 3 time points (acute) and/or in combination with activity-based upper extremity training (40 sessions, 1.5 hours/day, 5 days/week); stimulation will be applied intermittently for no more than 10 minutes at a time. Upper extremity training is based on usual care activities to challenge use of the hands and arms, e.g. reaching, grasping, manipulating objects.

Primary Outcome Measure

Incidence of skin irritation [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of NeurosurgeryLouisvilleKentucky40202
Lisa Clayton, BS
[email protected]
502-333-8152

Find similar trials in Louisville, KY

By research site
Department of Neurosurgery· Louisville, KY

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