Neuromodulation of Spinal Locomotor Circuitry to Elicit Stepping After Pediatric Spinal Cord Injury

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT04077346
Status
Enrolling By Invitation

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

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

Interventions

  • Biostim-5 transcutaneous spinal stimulator — DEVICE
    Transcutaneous spinal stimulation (TcStim): The 5-channel stimulator capable of generating (41) 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. TcStim will be delivered in combination with activity based locomotor training in 5 - 10 minute of stimulation at sub-motor threshold daily (5x/week) for 60 sessions
  • Transcutaneous Spinal Stimulator + Activity Based Locomotor Training — OTHER
    Participants will receive a combination of Activity-based locomotor training (AB-LT)+TcStim daily (5x/week) for 60 sessions and will consist of a minimum of 55-60 min on the TM for facilitated standing/stepping followed by 30 min of activities off TM in sitting, standing, or stepping.

Study Details

Spinal cord injury (SCI) results in damage to the descending neural pathways and leads to the immediate dysfunction of multiple physiological systems below the level of injury. Like adults, children with SCI suffer from neuromuscular paralysis which results in the inability to sit, stand, and walk. Current therapeutic interventions largely aim to compensate for paralysis to achieve mobility based on the assumption that damage to the central nervous system is permanent and irreversible, e.g. use of braces, standers, and wheelchairs. The objective of this proposal is to investigate the use of transcutaneous spinal stimulation (TcStim) to enable stepping in children with chronic SCI. The investigators will recruit 8 participants, ages 4-12 years with chronic, acquired SCI, T10 and above and non-ambulatory. The aims of this proposal are to 1) investigate the mechanisms of locomotor-specific regulation in the spinal neural circuitry of children with acquired SCI using single vs. multi-site TcStim, 2) investigate the capacity of the lumbosacral spinal cord for integration of task-specific input (e.g. load, speed) during facilitated stepping with and without TcStim, and 3) investigate the training effects of TcStim on the ability to step. Outcomes will provide a necessary initial step in the translation of scientific findings for neuromodulation from adults with SCI to children.

Key Dates

Start date
Apr 12, 2021
Status verified
Feb 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

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

Arms

  • Experimental: Transcutaneous Spinal Stimulation- Acute and with Training.
    For Aim 1: Participants will receive transcutaneous stimulation (TcStim) in supine or side lying position at a single or multi site spinal levels to produce stepping/locomotor activity in lower limbs. For Aim 2: TcStim will be delivered while participants are stepping on a computerized treadmill with an overhead partial body weight support (BWS) system and while stepping overground. For Aim 3: Participants will first receive a combination of Activity-based locomotor training (AB-LT)+TcStim for 60 sessions.

Primary Outcome Measure

Movement observation (live observation) with video review of the ability to initiate and take an independent, voluntary step from a position of standing. [ Time Frame: Change in ability to voluntarily step comparing pre-stimulation to during and post stimulation during session 1, session 2, session 3, and session 4 within 1 month of initiation and at session 1, 20, 40, and 60, within a 4 month period ]

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Neurosurgery, University of LouisvilleLouisvilleKentucky40202-

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By research site
Department of Neurosurgery, University of Louisville· Louisville, KY

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