Actively Recruiting

Phase Not Applicable
Age: 4Years - 18Years
All Genders
NCT04032990

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

Led by University of Louisville · Updated on 2024-06-24

10

Participants Needed

1

Research Sites

324 weeks

Total Duration

On this page

Sponsors

U

University of Louisville

Lead Sponsor

T

The Jewish Heritage Foundation for Excellence

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 4Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of chronic, acquired spinal cord injury more than 1 year ago
  • Injury involves cervical and/or high thoracic (T1) levels
  • Moderate to severe upper arm and hand weakness, scoring less than 4A on Pediatric Neuromuscular Recovery Upper Extremity Scale
  • Discharged from in-patient rehabilitation
Not Eligible

You will not qualify if you...

  • Botox use within the past 3 months
  • Current use of baclofen medication
  • Unhealed upper extremity fracture
  • Any medical condition limiting participation in assessments or training
  • Congenital spinal cord injury
  • Total ventilator dependence

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Neurosurgery

Louisville, Kentucky, United States, 40202

Actively Recruiting

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Research Team

L

Lisa Clayton, B.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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