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

NCT04077346 | Enrolling By Invitation FDA Device

• 1 other identifier: 19.0844
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

Pediatric-onset; Transcutaneous spinal stimulation; Stepping

Outcome Measures

Primary Outcomes (3)

• Movement observation (live observation) with video review of the ability to initiate and take an independent, voluntary step from a position of standing.

  Ability to take step independently with minimal or no external support. Participant can use a walker or other assistive device for balance and support. The participant will stand independently and lift a limb/foot off the ground and step forward making the same foot contact the ground in front as when taking a first step. This will be measured via movement observation by a licensed physical therapist and videotaped. A single step is all that is required. If more than one step is observed, this information will be documented and also videotaped. No manual assistance will be provided during the assessment for a voluntary step. The achievement of an independent step, foot leaves the ground and is placed forward, is the only criteria for the 'step'.

  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

• Electromyography (EMG) recording of lower extremity and trunk muscles

  Measurement of muscle and nerve functions. The muscle activities are reported in microvolts.

  Change in EMG: pre-stimulation compared to during 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

• Angular excursions of lower extremity

  Degrees of flexion/extension, adduction/abduction, and rotation, using wireless motion sensors.

  Change in limb angle excursions: Pre-stimulation compared to during-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

Study Arms (1)

Transcutaneous Spinal Stimulation- Acute and with Training.

EXPERIMENTAL

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.

Device: Biostim-5 transcutaneous spinal stimulator; Other: Transcutaneous Spinal Stimulator + Activity Based Locomotor Training

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 Stimulation- Acute and with Training.

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.

Transcutaneous Spinal Stimulation- Acute and with Training.

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with acquired, upper motor neuron (T10 and above) SCI, traumatic and non-traumatic,
• Chronic injury, defined as greater than one year post injury
• Age 4-12 years,
• Discharged from inpatient rehabilitation,
• Unable to stand, walk, or initiate steps.

You may not qualify if:

• Botox use within past 3 months
• Current oral baclofen use,
• Baclofen pump in use,
• Musculoskeletal impairment limiting range of motion, unhealed fracture or other medical complication limiting participation,
• Prior surgery for scoliosis, post SCI
• Congenital SCI,
• Total ventilator dependence.
• Unwilling or unable to wean from baclofen during training,
• Use of braces (trunk or lower limb brace).

Sponsors & Collaborators

• University of Louisville: lead
• Kentucky Spinal Cord and Head Injury Research Trust and Board: collaborator
• Kosair Charities, Inc.: collaborator

Study Sites (1)

Department of Neurosurgery, University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea L Behrman, PT, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: September 4, 2019
• Study Start: April 12, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)