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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT05091463
Status
Enrolling By Invitation

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
3 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Biostim-5/Neostim transcutaneous spinal stimulator — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2021
Status verified
Jun 2024
Primary completion
Jul 30, 2025
Completion
Jul 30, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Transcutaneous spinal stimulation
    Participants with chronic SCI will receive 60 sessions of activity based-locomotor training (AB-LT) combined with transcutaneous stimulation (scTS).

Primary Outcome Measure

Segmental Assessment of Trunk Control [ Time Frame: Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Kentucky Spinal Cord Injury Res Center, University of LouisvilleLouisvilleKentucky40202-

Find similar trials in Louisville, KY

By research site
Kentucky Spinal Cord Injury Res Center, University of Louisville· Louisville, KY

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