What is the mechanism of action of this treatment?

Noninvasive spinal stimulation, such as electrical stimulation applied through skin electrodes, works by delivering electrical impulses to the spinal cord and surrounding nerves. This stimulation can modulate neural activity, reduce spasticity (involuntary muscle activity), and improve motor control and pain management. For spinal cord injury patients, these mechanisms are crucial as they can enhance muscle function, decrease pain, and improve overall quality of life. By targeting specific neural pathways, electrical stimulation helps in restoring some degree of motor function and reducing the debilitating effects of spasticity and chronic pain.

What side effects are associated with this type of intervention?

Noninvasive spinal stimulation treatments, such as electrical stimulation applied through skin electrodes, are generally well-tolerated but can have mild side effects. These may include sensations of warmth, numbness in the arms or hands, redness, itching, tingling, muscle spasms, and localized pain in areas such as the arm, shoulder, or neck. Serious adverse events are rare.

What prior FDA approvals exist?

The FDA has approved various neuromodulation devices for the treatment of conditions related to spinal cord injury, including noninvasive spinal stimulation techniques. These treatments often involve electrical stimulation applied through skin electrodes. For example, transcutaneous electrical nerve stimulation (TENS) is a widely recognized method for managing pain, including in patients with spinal cord injuries. Additionally, spinal cord stimulation (SCS) devices, which involve the implantation of electrodes to deliver electrical pulses, have been approved for managing chronic pain associated with SCI. These devices aim to modulate pain signals and improve quality of life for patients.

What other types of research exist?

Promising novel alternatives to noninvasive spinal stimulation for spinal cord injury patients include: 1) Percutaneous electrical nerve stimulation (PENS), which involves inserting needles into soft tissue to deliver electrical stimulation, targeting specific dermatomal levels. 2) Advanced gastric electrical stimulation techniques, such as endoscopically-delivered miniaturized stimulators and multichannel stimulation protocols, which may be adapted for spinal cord injury treatment. 3) Diaphragm pacing systems, which have shown potential in improving respiratory function and could be explored for broader neuromodulation applications. These alternatives are in various stages of research and development, showing potential for enhanced efficacy and patient outcomes.

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Electrical Stimulation

Spinal Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Edelle Field-Fote, PT, PhD

Research Sponsored by Shepherd Center, Atlanta GA

Eligibility Criteria Checklist

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

Must have

Participants should be 16 years old or older

Must not have

People with broken skin

People with heart issues, such as atrial fibrillation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 25 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how different types of noninvasive electrical stimulation affect muscle issues and pain in people with spinal cord injuries. The treatment involves placing electrodes on the skin to send electrical pulses to the spine. Researchers hope to find the best way to use these pulses to reduce muscle problems and pain.

Who is the study for?

This trial is for individuals aged 16 or older who have had a spinal cord injury at least 3 months prior, with some leg spasticity. Participants should be able to follow instructions and communicate discomfort. They must consent to health information usage and report any changes in prescription medications during the study.

What is being tested?

The study tests how different frequencies of noninvasive spinal stimulation affect muscle control, involuntary muscle activity (spasticity), and pain after a spinal cord injury. It involves electrical stimulation over the lower back and stomach, requiring visits to Shepherd Center for sessions across several weeks.

What are the potential side effects?

Potential side effects may include discomfort or pain at the stimulation site, skin irritation from electrodes, temporary increase in spasticity or muscle weakness post-treatment. The severity can vary among individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am 16 years old or older.

Exclusion Criteria

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

Select...

I have broken skin.

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I have a heart condition like atrial fibrillation.

Select...

I have received long-term treatments for muscle stiffness.

Select...

My spinal cord injury is below the T12 level.

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My spinal condition is worsening over time.

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I have bone or joint issues that could interfere with study participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 25 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~25 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 minutes for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pendulum Test

Secondary study objectives

Ankle Clonus Test

Global Rating of Change Scale

Modified Penn Spasm Frequency Scale

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: 80 Hz FrequencyExperimental Treatment1 Intervention

Intervention will be applied with an 80 Hz frequency.

Group II: 50 Hz FrequencyExperimental Treatment1 Intervention

Intervention will be applied with a 50 Hz frequency.

Group III: 30 Hz FrequencyExperimental Treatment1 Intervention

Intervention will be applied with a 30 Hz frequency.

0 / 7Eligibility 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

Noninvasive spinal stimulation, such as electrical stimulation applied through skin electrodes, works by delivering electrical impulses to the spinal cord and surrounding nerves. This stimulation can modulate neural activity, reduce spasticity (involuntary muscle activity), and improve motor control and pain management. For spinal cord injury patients, these mechanisms are crucial as they can enhance muscle function, decrease pain, and improve overall quality of life. By targeting specific neural pathways, electrical stimulation helps in restoring some degree of motor function and reducing the debilitating effects of spasticity and chronic pain.