Recruiting

Transcutaneous Spinal Stimulation

Sponsor:

University of Louisville

Code:

NCT04032990

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 4 - 18

Healthy Volunteers: Not accepted

Interventions

Biostim-5 transcutaneous spinal stimulator

Study Details

Brief 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.

Conditions

Spinal Cord Injuries

Study ID

NCT04032990

Start date

Nov 14, 2019

Status verified date

Jun, 2024

Completion date

Feb, 2026

Anticipated

Primary completion date

Feb 28, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

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.

Interventions

Biostim-5 transcutaneous spinal stimulator

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

Primary outcome measure

  • Incidence of skin irritation [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]
  • Faces Pain Scale-Revised (scale 0-10) [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]
  • Visual Analog Scale (0-10) [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]
  • Blood pressure [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]
  • Number of requests to stop the stimulation [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]
  • Angular excursions of upper extremity and hand [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]
  • Hand Grip strength [ Time Frame: within 2 months for Aim 1, within 3 months for Aim 2 ]

Central Contacts and Locations

Central contacts

Lisa Clayton, B.S.

502-333-8152Lisa.Clayton@louisville.edu

Locations

Department of Neurosurgery

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Lisa Clayton, BS

502-333-8152Lisa.Clayton@louisville.edu

More Information

Sponsor

University of Louisville

Last update posted

Jun 24, 2024

Last verified

Jun, 2024

Keywords

  • pediatric-onset
  • transcutaneous spinal stimulation
  • upper extremity function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2024-06-24.