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Transcutaneous Spinal Stimulation for Upper Limb Function in Children With Spinal Cord Injury

This study is testing a new therapy called Biostim-5 transcutaneous spinal stimulator (a device that delivers electrical stimulation through the skin) for children aged 4 to 18 years old who have a spinal cord injury (SCI) in their neck or upper back. These children often have difficulty using their hands and arms. The study aims to see if this stimulation, combined with practicing movements like grasping and pinching, is safe, comfortable, and practical. Success will be measured by how often skin irritation occurs and by pain levels, assessed within 2 to 3 months. The goal is to help children with SCI improve their arm and hand function for daily tasks and play. The study plans to enroll 10 participants, and its current status is unclear.

Study design
This is an interventional study planning to enroll 10 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for skin irritation and pain levels within 2 to 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04032990

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

UNKNOWN
NAAges 4–18InterventionalDevice feasibility
University of Louisville
~10 participants
Updated 2024-06-24 on ClinicalTrials.gov
What's tested:Biostim-5 transcutaneous spinal stimulator

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of skin irritation
Measured over within 2 months for Aim 1, within 3 months for Aim 2
+6 more outcomes measured

Conditions

Spinal Cord Injuries

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Andrea L Behrman, PT, PhD · PRINCIPAL_INVESTIGATOR · University of Louisville

Who to contact

Lisa Clayton, B.S.
[email protected]
502-333-8152
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of skin irritationwithin 2 months for Aim 1, within 3 months for Aim 2

    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.

  • Faces Pain Scale-Revised (scale 0-10)within 2 months for Aim 1, within 3 months for Aim 2

    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.

  • Visual Analog Scale (0-10)within 2 months for Aim 1, within 3 months for Aim 2

    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.

  • Blood pressurewithin 2 months for Aim 1, within 3 months for Aim 2

    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);

  • Number of requests to stop the stimulationwithin 2 months for Aim 1, within 3 months for Aim 2

    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)

  • Angular excursions of upper extremity and handwithin 2 months for Aim 1, within 3 months for Aim 2

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

  • Hand Grip strengthwithin 2 months for Aim 1, within 3 months for Aim 2

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