MedTrace Logo

Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric SCI

NCT05091463 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-06-24

No results posted yet for this study

Summary

The overall purpose of this study is to test the efficacy of multi-modal training combining activity-based locomotor training and transcutaneous spinal stimulation (ABLT+scTS) to improve sitting posture and trunk control in children with a chronic spinal cord injury.

The investigators will recruit 12 participants, ages 3-12 with chronic, acquired SCI, T10 and above and non-ambulatory. The participants in this study will be novices to scTS and AB-LT.

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

Biostim-5/Neostim transcutaneous spinal stimulator

Transcutaneous spinal stimulation (scTS): The 5-channel stimulator capable of generating pain-free biphasic rectangular waveform of 0.3 to 1.0 ms pulses with a frequency of 5-10 kHz will be used to stimulate at single or multi-site spinal levels. Transcutaneous stimulation will be delivered in combination with activity based locomotor training in 5-10 minute bouts of stimulation at sub-motor threshold during daily sessions (5x/week) lasting for 90 minutes for a total of 60 sessions of therapy. The sessions will consist of 55-60 minutes on the treadmill for facilitated standing/stepping followed by 30 minutes of activities off the treadmill in sitting, standing, or stepping.

Sponsors & Collaborators

  • The Craig H. Neilsen Foundation

    collaborator OTHER

  • University of Louisville

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2025-07-30
Completion
2026-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05091463 on ClinicalTrials.gov