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

NCT04032990 | Recruiting FDA Device

• 1 other identifier: 19.0810
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

pediatric-onset; transcutaneous spinal stimulation; upper extremity function

Outcome Measures

Primary Outcomes (7)

• Incidence of skin irritation

  Skin color, particularly change in skin color to pink indicating irritation in the location of the stimulating electrode placement will be assessed prior to stimulation experiments and immediately after; incidence of pink- or redness or irritation and time (minutes-days) to dissipation will be recorded.

  within 2 months for Aim 1, within 3 months for Aim 2

• Faces Pain Scale-Revised (scale 0-10)

  Faces Pain Scale - Revised is a self-report measure of pain intensity developed for children (C.L. Hicks et al. Pain 93 (2001). It will be used to score the sensation of pain on 0 (min - no pain)-to-10 (max - worst pain ever) metric. The scale depicts 6 facial expressions: first - face with a neutral expression corresponds to pain score of 0, next facial expression is scored as 2, etc. The faces scale will be presented to the participant (ages 3-8) prior to the experiment for baseline measurement, during stimulation and following the experiment.

  within 2 months for Aim 1, within 3 months for Aim 2

• Visual Analog Scale (0-10)

  To assess pain in the participants ages 8 and above, Visual Analog Scale (self-reported measure) will be presented with 0 corresponding to no pain and 10 corresponding to the "worst pain ever"; the scale will be presented at baseline measurement, during stimulation and following the experiment.

  within 2 months for Aim 1, within 3 months for Aim 2

• Blood pressure

  continuous beat-by-beat blood pressure (mmHg) recordings will be made using Finapres finger cuff system for 5 minutes prior to and 5 minutes immediately following stimulation while the child is sitting; Brachial arm blood pressure will be periodically measured during stimulation (mmHg). systolic and diastolic blood pressure values will be compared with the established norms for typically developing children (age and height matched);

  within 2 months for Aim 1, within 3 months for Aim 2

• Number of requests to stop the stimulation

  Number of participants requesting (or number of request per participant within experimental sessions) to stop stimulation due to pain, fatigue or any other reason (documented)

  within 2 months for Aim 1, within 3 months for Aim 2

• Angular excursions of upper extremity and hand

  degrees of flexion/extension, adduction/abduction in elbow, shoulder, wrist, fingers

  within 2 months for Aim 1, within 3 months for Aim 2

• Hand Grip strength

  A hand grip strength dynamometer will be used to assess strength (Newton)

  within 2 months for Aim 1, within 3 months for Aim 2

Secondary Outcomes (3)

• Heart Rate

  within 2 months for Aim 1, within 3 months for Aim 2

• Compliance rate

  within 2 months for Aim 1, within 3 months for Aim 2

• Angular excursions of trunk during trunk control assessments

  within 2 months for Aim 1, within 3 months for Aim 2

Study Arms (1)

Transcutaneous spinal stimulation - Acute and Training

EXPERIMENTAL

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.

Device: Biostim-5 transcutaneous spinal stimulator

Interventions

Biostim-5 transcutaneous spinal stimulator DEVICE

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

Transcutaneous spinal stimulation - Acute and Training

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• The Jewish Heritage Foundation for Excellence: collaborator

Study Sites (1)

Department of Neurosurgery

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (1)

• Singh G, Keller A, Lucas K, Borders C, Stout D, King M, Parikh P, Stepp N, Ugiliweneza B, D'Amico JM, Gerasimenko Y, Behrman AL. Safety and Feasibility of Cervical and Thoracic Transcutaneous Spinal Cord Stimulation to Improve Hand Motor Function in Children With Chronic Spinal Cord Injury. Neuromodulation. 2024 Jun;27(4):661-671. doi: 10.1016/j.neurom.2023.04.475. Epub 2023 Jun 1.

  PMID: 37269282 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Andrea L Behrman, PT, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Clayton, B.S.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 25, 2019
• Study Start: November 14, 2019
• Primary Completion: February 28, 2025
• Study Completion: February 1, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)