What side effects are associated with this type of intervention?

Common treatments for spinal cord injury, particularly those involving neuromodulation like Transcutaneous Spinal Stimulation (TcStim), generally have minor and infrequent side effects. These can include sensations such as tingling, lightheadedness, and mild discomfort at the site of stimulation. More serious adverse events are rare. Other neuromodulation techniques, such as Transcranial Magnetic Stimulation (TMS), have similar side effects, including lightheadedness, tingling, and in rare cases, tinnitus. Overall, these treatments are considered safe with a low risk of significant adverse effects.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for various conditions, but specific approvals for Transcutaneous Spinal Stimulation (TcStim) for Spinal Cord Injury (SCI) are not detailed in the provided context. However, neuromodulation techniques such as Transcutaneous Electrical Nerve Stimulation (TENS) and Spinal Cord Stimulation (SCS) have been explored for pain management and functional improvement in SCI patients. These treatments aim to modulate neural activity to alleviate symptoms and improve quality of life.

What other types of research exist?

Promising novel alternatives to Transcutaneous Spinal Stimulation for SCI patients include Spinal Cord Stimulation (SCS), which has shown efficacy in multiple randomized controlled trials for pain relief and functional improvement. Additionally, percutaneous electrical nerve stimulation (PENS) and high-frequency spinal cord stimulation (10 kHz SCS) are emerging therapies with positive outcomes in clinical studies. These alternatives offer potential benefits in managing pain and improving mobility in SCI patients.

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Neuromodulation

Neuromodulation Therapy for Spinal Cord Injury

N/A

Waitlist Available

Led By Andrea L Behrman, PT, PhD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unable to stand, walk, or initiate steps

Age 4-12 years

Must not have

Prior surgery for scoliosis, post SCI

Botox use within past 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of TcStim may include discomfort at the stimulation site, skin irritation under electrode pads and muscle fatigue due to exercise involved in locomotor training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 4 and 12 years old.

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

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I have been discharged from inpatient rehab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have not used Botox in the last 3 months.

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I am currently taking oral baclofen.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Angular excursions of lower extremity

Electromyography (EMG) recording of lower extremity and trunk muscles

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcutaneous Spinal Stimulation (TcStim) is a neuromodulation technique that aims to restore motor function in Spinal Cord Injury (SCI) patients by delivering electrical currents through the skin to modulate spinal neural circuits. This stimulation helps to activate and regulate the spinal locomotor networks, which can facilitate stepping and other motor activities. By enhancing the communication between the peripheral nerves and the central nervous system, TcStim can improve motor control and reduce spasticity. These mechanisms are crucial for SCI patients as they offer a non-invasive method to potentially regain mobility and improve their quality of life.