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Device

Transcutaneous Spinal Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Andrea L Behrman, PT, PhD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

SCI involves cervical and/or high thoracic (T1) levels

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 months for aim 1, within 3 months for aim 2

Awards & highlights

Study Summary

This trial is testing a new therapy to help children with spinal cord injuries in the neck region regain use of their arms and hands.

Who is the study for?

This trial is for children with chronic spinal cord injuries in the neck or high thoracic area, who have been injured for over a year and struggle to use their arms and hands. They should be past in-patient rehab but not using certain muscle relaxants or have unhealed fractures.Check my eligibility

What is being tested?

The trial tests a new therapy using the Biostim-5 device to stimulate the spinal cord while kids practice movements like grasping and reaching. The aim is to see if it's safe, comfortable, and practical for improving arm function.See study design

What are the potential side effects?

While specific side effects are not listed, potential risks may include discomfort at the stimulation site, skin irritation from the device, or unexpected reactions affecting muscle control during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have difficulty using my arms for tasks like reaching overhead or grasping.

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My spinal cord injury is in the neck or upper back area.

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I have been discharged from in-patient rehabilitation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 months for aim 1, within 3 months for aim 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 months for aim 1, within 3 months for aim 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 months for aim 1, within 3 months for aim 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Angular excursions of upper extremity and hand

Blood pressure

Faces Pain Scale-Revised (scale 0-10)

+4 more

Secondary outcome measures

Angular excursions of trunk during trunk control assessments

Compliance rate

Heart rate

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcutaneous spinal stimulation - Acute and TrainingExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,974 Total Patients Enrolled

The Jewish Heritage Foundation for ExcellenceUNKNOWN

Andrea L Behrman, PT, PhDPrincipal InvestigatorUniversity of Louisville

2 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Biostim-5 transcutaneous spinal stimulator (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04032990 — N/A

Spinal Cord Injury Research Study Groups: Transcutaneous spinal stimulation - Acute and Training

Spinal Cord Injury Clinical Trial 2023: Biostim-5 transcutaneous spinal stimulator Highlights & Side Effects. Trial Name: NCT04032990 — N/A

Biostim-5 transcutaneous spinal stimulator (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04032990 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the application criteria for this medical study include individuals below 80 years of age?

"This trial only accepts young patients aged 4 to 18. For the population younger than 18, there are 138 studies available; comparably, adults over 65 can choose from 732 different clinical trials."

Answered by AI

How many participants are being included in this clinical research?

"Indeed, clinicaltrials.gov shows that this medical study first commenced on November 14th 2019 and is looking for recruits as of March 25th 2022. So far 10 individuals have been enrolled from 1 site."

Answered by AI

Are researchers still recruiting participants for this examination?

"This research project is currently receiving applicants, as evidenced by its listing on clinicaltrials.gov which was first posted in November 14th 2019 and amended most recently on March 25th 2022."

Answered by AI

What criteria must potential participants meet to qualify for this research study?

"In order to partake in this clinical trial, prospective participants must have suffered a spinal cord injury and be between the ages of 4-18. Altogether, 10 people will be admitted into the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Andrea L. Behrman, PhD, PT 2019. "Transcutaneous Spinal Stimulation: Safety and Feasibility for Upper Limb Function in Children With Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04032990.

All > Spinal Cord Injury > Spinal Cord