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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 31, 2021

Primary Completion Date

July 30, 2025

Study Completion Date

July 30, 2026

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.

Trial Locations (1)

40202

Kentucky Spinal Cord Injury Res Center, University of Louisville, Louisville

All Listed Sponsors
collaborator

The Craig H. Neilsen Foundation

OTHER

lead

University of Louisville

OTHER