Neuromodulation Therapy for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen ByAndrea L Behrman, PT, PhD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Louisville

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial aims to test if electrical stimulation through the skin can help children with severe spinal cord injuries improve their ability to move and walk. The study will involve 8 children who cannot walk due to their injuries. Researchers hope that this treatment can reactivate the nerves in the spinal cord to help these children regain some movement. Electrical stimulation has been studied for its potential to improve movement and posture in individuals with spinal cord injuries.

Eligibility Criteria

This trial is for children aged 4-12 with chronic spinal cord injury (SCI) at T10 or above, who can't stand, walk, or initiate steps. They must be more than a year post-injury and discharged from inpatient rehab. Kids with recent Botox use, scoliosis surgery after SCI, congenital SCI, baclofen treatments, musculoskeletal issues affecting movement, unhealed fractures or total ventilator dependence cannot join.

Inclusion Criteria

I cannot stand, walk, or start walking on my own.

I am between 4 and 12 years old.

My child has had a spinal cord injury above T10 for over a year.

I have been discharged from inpatient rehab.

Exclusion Criteria

I have had surgery for scoliosis after a spinal cord injury.

I have not used Botox in the last 3 months.

I am currently taking oral baclofen.

I have a physical condition that limits my movement or an unhealed fracture.

Participant Groups

The study tests if transcutaneous spinal stimulation (TcStim), using the Biostim-5 device combined with locomotor training can help children step again after an SCI. It will explore how this method affects the spinal circuitry during stepping tasks and whether it improves their ability to step over time.

1Treatment groups

Experimental Treatment

Group I: Transcutaneous Spinal Stimulation- Acute and with Training.Experimental Treatment2 Interventions

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.