What is the mechanism of action of this treatment?

Spinal cord stimulation (SCS) involves the use of electrical impulses to modulate nerve activity in the spinal cord, aiming to reduce pain and improve function. The mechanism of action includes altering pain signal transmission and enhancing neural plasticity, which can help restore some motor and sensory functions. This is particularly relevant for SCI patients as it offers a potential method to alleviate chronic pain and improve quality of life, especially for those who are dependent on mechanical ventilation or have limited mobility. Understanding these mechanisms helps in tailoring treatments to individual needs and optimizing therapeutic outcomes.

What side effects are associated with this type of intervention?

Common side effects of electrical stimulation treatments for Spinal Cord Injury include mild device-associated events such as a warm sensation, numbness in the arm or hand, redness, itching, tingling, muscle spasms, and localized pain in the arm, shoulder, or neck. Serious adverse events are rare, but there is a theoretical risk of triggering seizures in patients with epilepsy.

What prior FDA approvals exist?

The FDA has approved various treatments for spinal cord injury, including electrical stimulation methods. One notable approval is for the use of the Enterra Therapy system, a gastric electrical neurostimulator, which has been approved as a humanitarian exemption device for certain conditions. However, specific FDA approvals for cervical spinal cord stimulators for respiratory function in spinal cord injury patients are still under investigation, as seen in the phase 1 study focusing on safety and feasibility. This study targets individuals with cervical spinal cord injuries who are ventilator-dependent, aiming to improve their respiratory function through electrical stimulation.

What other types of research exist?

Promising novel alternatives to Cervical Spinal Cord Stimulator for SCI patients include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which provides symptomatic relief by modifying pain perception through surface electrodes. 2) Percutaneous Electrical Nerve Stimulation (PENS), which involves inserting acupuncture-like needles into soft tissue and applying low-level electrical stimulation targeting dermatomal levels. Both methods have shown varying degrees of efficacy in clinical trials and may offer non-invasive or minimally invasive options for pain management and functional improvement in SCI patients.

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Neuromodulation

Neuromodulation for Spinal Cord Injury

N/A

Recruiting

Led By Daniel C Lu, MD, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

Male or female 18-75 years.

> 1 year post-injury.

Must not have

Phrenic nerve paralysis.

Musculoskeletal dysfunction, unhealed fracture, pressure ulcer, active infection.

Timeline

Screening 1 days

Treatment Varies

Follow Up 2 days

Awards & highlights

Summary

This trial tests a small device placed near the neck's spinal cord to help people with severe spinal injuries who need ventilators. It aims to see if electrical signals from the device can improve their breathing. The study focuses on adults aged 18-75 with injuries between C2 and C7 vertebrae. The goal is to reduce the need for ventilators in these patients.

Who is the study for?

This trial is for adults aged 18-75 with a spinal cord injury at levels C2 to C7, who rely on ventilators due to severe respiratory issues. They must be over a year post-injury, able to attend weekly sessions for up to 21 months, and have intact cognitive abilities. Excluded are those with recent lung surgery, active lung diseases, phrenic nerve paralysis or pacers, musculoskeletal issues like unhealed fractures or infections.

What is being tested?

The study tests the safety and feasibility of implanting a cervical spinal cord stimulator in patients dependent on mechanical ventilation due to cervical SCI. It's an early-stage (phase 1) trial focusing on whether this approach can improve respiratory function in affected individuals.

What are the potential side effects?

As this is a phase 1 trial primarily assessing safety and feasibility of epidural stimulation for breathing support in spinal cord injuries, specific side effects are not listed but may include discomfort or complications related to device implantation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 75 years old.

Select...

It has been over a year since my injury.

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My spinal cord injury between the C2 and C7 vertebrae is stable.

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I have complete motor paralysis according to the ASIA scale.

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I rely on a ventilator and have low breathing strength.

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I can go to weekly tests for up to 21 months.

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I am between 18 and 75 years old.

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I have a spinal cord injury in my neck area.

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I have severe breathing problems.

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My chest, arms, and legs are structurally normal, and my muscles work properly.

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I can understand, follow instructions, and express my concerns.

Exclusion Criteria

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

Select...

I have paralysis of the phrenic nerve.

Select...

I do not have any broken bones, muscle issues, open wounds, or infections.

Select...

I had lung surgery within the last year or have a lung condition like asthma or COPD.

Timeline

Screening ~ 1 days0 visits

Treatment ~ Varies

Follow Up ~ 2 days91 visits

Screening ~ 1 days

Treatment ~ Varies

Follow Up ~2 days

This trial's timeline: 1 days for screening, Varies for treatment, and 2 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4

Secondary study objectives

Evaluating Pulmonary Function Throughout the Duration of the Study; 20%

Evaluating Pulmonary Function Throughout the Duration of the Study; 20% increase in minute ventilation.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Epidural Stimulation for Respiratory FunctionExperimental Treatment1 Intervention

Self-controlled longitudinal safety and feasibility of stimulation and respiratory training.

0 / 14Eligibility 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) involves the use of electrical impulses to modulate nerve activity in the spinal cord, aiming to reduce pain and improve function. The mechanism of action includes altering pain signal transmission and enhancing neural plasticity, which can help restore some motor and sensory functions. This is particularly relevant for SCI patients as it offers a potential method to alleviate chronic pain and improve quality of life, especially for those who are dependent on mechanical ventilation or have limited mobility. Understanding these mechanisms helps in tailoring treatments to individual needs and optimizing therapeutic outcomes.

Management of patients with pain.