RecruitingNot ApplicableNCT04032990

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

Transcutaneous Spinal Stimulation Promoting Recovery of Hand and Arm Function After Pediatric-onset Spinal Cord Injury


Sponsor

University of Louisville

Enrollment

10 participants

Start Date

Nov 14, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 4 YearsMax Age: 18 Years

Inclusion Criteria4

  • history of chronic, acquired SCI, (>1 year since injury);
  • SCI involves cervical and/or high thoracic (T1) levels
  • moderate to severe upper extremity deficit as assessed by the Pediatric Neuromuscular Recovery Upper Extremity Scale (scores less than 4A out of a 12 point range from 1A-4C on upper extremity tasks, e.g. including inability to fully reach overhead, grasp, or pinch without compensation)
  • discharged from in-patient rehabilitation

Exclusion Criteria6

  • botox use within past 3 months;
  • current baclofen use
  • unhealed upper extremity fracture
  • any other medical complication limiting participation in the assessments and/or activity- based upper extremity training;
  • congenital SCI
  • total ventilator dependence

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Interventions

DEVICEBiostim-5 transcutaneous spinal stimulator

Safety and feasibility will be monitored during transcutaneous spinal stimulation in children with spinal cord injury


Locations(1)

Department of Neurosurgery

Louisville, Kentucky, United States

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NCT04032990


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