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ENROLLING BY INVITATION
NCT05091463
NA

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

Sponsor: University of Louisville

View on ClinicalTrials.gov

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.

Official title: Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric Spinal Cord Injury

Key Details

Gender

All

Age Range

3 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2021-08-31

Completion Date

2026-07-30

Last Updated

2024-06-24

Healthy Volunteers

No

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.

Locations (1)

Kentucky Spinal Cord Injury Res Center, University of Louisville

Louisville, Kentucky, United States