What is the mechanism of action of this treatment?

Electrical stimulation treatments, such as Transcutaneous Closed-Loop Electrical Spinal Cord Stimulation, work by delivering electrical currents to the spinal cord through the skin. This stimulation modulates neural circuits, potentially enhancing motor function and reducing spasticity in SCI patients. By targeting specific neural pathways, these treatments can help restore some degree of voluntary movement and improve overall quality of life. This is particularly important for SCI patients as it offers a non-invasive option to regain function and independence, addressing both physical and psychological aspects of recovery.

What side effects are associated with this type of intervention?

Common treatments for spinal cord injury similar to transcutaneous closed-loop electrical spinal cord stimulation include various forms of electrical stimulation such as transcutaneous electrical nerve stimulation (TENS) and spinal cord stimulation (SCS). Known side effects of these treatments can include mild device-associated adverse events such as a warm sensation, numbness in the arm or hand, redness, itching, tingling, muscle spasm, arm pain, shoulder pain, and neck pain. Serious adverse events are rare but can include the risk of triggering seizures in patients with epilepsy when using transcranial magnetic stimulation (TMS).

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments of spinal cord injury that are similar to transcutaneous closed-loop electrical spinal cord stimulation. However, it does discuss various neuromodulation techniques and electrical stimulation methods being studied for their efficacy in treating conditions like chronic pain and neuropathy, which may share some therapeutic principles with spinal cord injury treatments. For precise information on FDA-approved treatments, consulting additional resources or clinical guidelines would be necessary.

What other types of research exist?

Promising alternatives to Transcutaneous Closed-Loop Electrical Spinal Cord Stimulation for SCI patients include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which has shown efficacy in pain management and functional recovery; 2) Transcranial Magnetic Stimulation (TMS), which has potential benefits in neurorehabilitation; and 3) Epidural Electrical Stimulation (EES), which has demonstrated improvements in motor function and spasticity in SCI patients. These alternatives offer non-invasive or minimally invasive options with varying mechanisms of action to modulate neural circuits and promote recovery.

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Spinal Cord Stimulation

Spinal Cord Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Chet Moritz, Ph.D.

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Has difficulty with hand functions in activities of daily living (e.g., dressing, grooming, feeding)

Stable medical condition without cardiopulmonary disease or autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities

Must not have

Has history of neurologic diseases, such as stroke, multiple sclerosis, traumatic brain injury, etc.

Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up "repeated measurements once every two weeks throughout the study, an average of 10 months".

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a treatment that uses electrical signals sent through the skin to help people with spinal cord injuries improve arm movement and reduce muscle stiffness. The treatment involves placing electrodes on the neck and using sensors to detect movement. The goal is to see if this method can better help patients regain function and reduce stiffness.

Who is the study for?

This trial is for adults with a stable medical condition who have had a cervical spinal cord injury at least one year ago, can perform simple motor tasks, and attend sessions three times weekly. They must not be ventilator-dependent or have certain implants, drug abuse history, pregnancy, severe allergies, or other conditions that could interfere with the study.

What is being tested?

The study tests non-invasive closed-loop electrical stimulation versus open-loop stimulation to improve hand function and reduce spasticity after spinal cord injuries. Participants will also engage in functional task practice as part of their therapy regimen.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from the electrical stimulation or skin irritation where electrodes are placed. There might also be risks associated with increased physical activity during rehabilitation.

Eligibility Criteria

Inclusion Criteria

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

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I struggle with daily tasks like dressing or feeding due to hand issues.

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My heart and lung health allows me to do arm exercises.

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I have a spinal cord injury above my shoulders and still have some movement or sensation below the injury.

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I can attend training and assessment sessions 3 times a week.

Exclusion Criteria

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

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I have a history of neurological diseases like stroke or MS.

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I have nerve damage in my hands or feet.

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I do not have any unhealed injuries or frequent infections that could affect my arm rehabilitation.

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I am currently taking tizanidine, dantrolene, or diazepam.

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I have had botulinum toxin injections in my arm muscles within the last 6 months.

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I have had surgery to move tendons or nerves in my arm or hand.

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I rely on a machine to help me breathe.

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I have a history of chronic headaches or migraines.

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I have cancer.

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I have a rheumatic disease like rheumatoid arthritis or lupus.

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I have a heart or muscle condition that stops me from fully joining in physical therapy.

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I have or had syringomyelia with symptoms like pain, weakness, sensory loss, or issues with bowel/bladder.

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I do not have uncontrolled high blood pressure or serious heart, lung, or blood clotting issues.

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My spinal cord injury is due to an autoimmune disease.

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I have a history of seizures or am at high risk for seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ "repeated measurements once every two weeks throughout the study, an average of 10 months".

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~"repeated measurements once every two weeks throughout the study, an average of 10 months".

This trial's timeline: 3 weeks for screening, Varies for treatment, and "repeated measurements once every two weeks throughout the study, an average of 10 months". for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline- Capabilities of Upper Extremity Test

Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2

Change from baseline- Grip and Pinch Force

+1 more

Secondary study objectives

Change from baseline Spinal Cord Independence Measure Self Report

Change from baseline- H-Reflex

Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Motor Score

+4 more

Other study objectives

Change from baseline- International Spinal Cord Injury Bowel Function Basic Data Set.v.2.1

Change from baseline- Patient Reported Impact of Spasticity Measure

Change from baseline- Spinal Cord Injury - Functional Index Short-Form

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Open-loop StimulationExperimental Treatment2 Interventions

Continuous stimulation

Group II: Close-loop StimulationExperimental Treatment2 Interventions

Intended movement-based stimulation.

0 / 19Eligibility 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

Electrical stimulation treatments, such as Transcutaneous Closed-Loop Electrical Spinal Cord Stimulation, work by delivering electrical currents to the spinal cord through the skin. This stimulation modulates neural circuits, potentially enhancing motor function and reducing spasticity in SCI patients. By targeting specific neural pathways, these treatments can help restore some degree of voluntary movement and improve overall quality of life. This is particularly important for SCI patients as it offers a non-invasive option to regain function and independence, addressing both physical and psychological aspects of recovery.