What is the mechanism of action of this treatment?

Spinal cord stimulation (SCS) and transcutaneous electrical nerve stimulation (TENS) are common treatments for spinal cord injury that involve electrical stimulation. SCS works by delivering electrical impulses to the spinal cord through implanted electrodes, which can modulate pain signals and improve motor function by enhancing neural plasticity and facilitating the activation of spinal circuits. TENS, on the other hand, uses surface electrodes to deliver electrical impulses that can help reduce pain and improve muscle activation by altering pain perception and stimulating nerve pathways. These treatments are crucial for SCI patients as they can significantly improve pain management, enhance motor function, and ultimately improve the quality of life by enabling better control over muscle movements and reducing discomfort.

What side effects are associated with this type of intervention?

Common treatments for spinal cord injury, such as spinal cord stimulation (SCS) and other forms of electrical stimulation, generally have mild side effects. These can include sensations such as tingling, warmth, or numbness in the treated area. Some patients may experience muscle spasms, redness, itching, or lightheadedness. Serious adverse events are rare, but there is a theoretical risk of triggering seizures in patients with epilepsy when using transcranial magnetic stimulation (TMS). Overall, these treatments are considered safe with minor and infrequent side effects.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for various conditions, but specific approvals for spinal cord injury treatments involving electrical stimulation are limited. One notable device is the gastric electrical neurostimulator (Enterra Therapy system), approved for gastroparesis, which demonstrates the potential of electrical stimulation in treating refractory symptoms. While this device is not specifically for SCI, it highlights the broader application of electrical stimulation in medical treatments. For SCI, investigational therapies like transcutaneous spinal stimulation are being studied to enhance muscle activation and improve upper limb function, but these are not yet FDA-approved.

What other types of research exist?

Promising novel alternatives to Spinal Cord Stimulation for SCI patients include: 1) Transcutaneous Spinal Stimulation, which has shown safety and feasibility for improving upper limb function in children with SCI. 2) Transcranial Magnetic Stimulation (TMS), which has demonstrated efficacy in modulating neural excitability and improving motor function. 3) Noninvasive Vagus Nerve Stimulation (nVNS), which may offer benefits for neuromodulation without the need for invasive procedures.

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Device

Transcutaneous Spinal Stimulation for Spinal Cord Injury

N/A

Recruiting

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

Moderate to severe upper extremity deficit as assessed by the Pediatric Neuromuscular Recovery Upper Extremity Scale (scores less than 4A out of a 12 point range from 1A-4C on upper extremity tasks, e.g. including inability to fully reach overhead, grasp, or pinch without compensation)

SCI involves cervical and/or high thoracic (T1) levels

Must not have

Unhealed upper extremity fracture

Current baclofen use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 months for aim 1, within 3 months for aim 2

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new therapy using mild electrical stimulation and exercises to help children with neck spinal cord injuries improve their arm and hand movements. The goal is to make it easier for these children to play and do everyday tasks. This approach has been shown to increase independence and reduce the need for help and special equipment in children and adolescents with spinal cord injuries.

Who is the study for?

This trial is for children with chronic spinal cord injuries in the neck or high thoracic area, who have been injured for over a year and struggle to use their arms and hands. They should be past in-patient rehab but not using certain muscle relaxants or have unhealed fractures.

What is being tested?

The trial tests a new therapy using the Biostim-5 device to stimulate the spinal cord while kids practice movements like grasping and reaching. The aim is to see if it's safe, comfortable, and practical for improving arm function.

What are the potential side effects?

While specific side effects are not listed, potential risks may include discomfort at the stimulation site, skin irritation from the device, or unexpected reactions affecting muscle control during treatment.

Eligibility Criteria

Inclusion Criteria

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

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I have difficulty using my arms for tasks like reaching overhead or grasping.

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My spinal cord injury is in the neck or upper back area.

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I have been discharged from in-patient rehabilitation.

Exclusion Criteria

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

Select...

I have a broken arm or hand that hasn't healed.

Select...

I am currently taking baclofen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 months for aim 1, within 3 months for aim 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 months for aim 1, within 3 months for aim 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 months for aim 1, within 3 months for aim 2 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 upper extremity and hand

Blood pressure

Faces Pain Scale-Revised (scale 0-10)

+4 more

Secondary study objectives

Angular excursions of trunk during trunk control assessments

Compliance rate

Heart rate

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 TrainingExperimental Treatment1 Intervention

Safety and feasibility outcome measures are collected during application of transcutaneous spinal stimulation while upper extremity function is assessed at 3 time points (acute) and/or in combination with activity-based upper extremity training (40 sessions, 1.5 hours/day, 5 days/week); stimulation will be applied intermittently for no more than 10 minutes at a time. Upper extremity training is based on usual care activities to challenge use of the hands and arms, e.g. reaching, grasping, manipulating objects.

0 / 5Eligibility 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

Spinal cord stimulation (SCS) and transcutaneous electrical nerve stimulation (TENS) are common treatments for spinal cord injury that involve electrical stimulation. SCS works by delivering electrical impulses to the spinal cord through implanted electrodes, which can modulate pain signals and improve motor function by enhancing neural plasticity and facilitating the activation of spinal circuits. TENS, on the other hand, uses surface electrodes to deliver electrical impulses that can help reduce pain and improve muscle activation by altering pain perception and stimulating nerve pathways. These treatments are crucial for SCI patients as they can significantly improve pain management, enhance motor function, and ultimately improve the quality of life by enabling better control over muscle movements and reducing discomfort.

Combined Supra- and Sub-Lesional Epidural Electrical Stimulation for Restoration of the Motor Functions after Spinal Cord Injury in Mini Pigs.