What side effects are associated with this type of intervention?

Vagus Nerve Stimulation (VNS) for spinal cord injury is generally considered safe, with side effects including hoarseness, throat pain, cough, shortness of breath, and in rare cases, infection at the implantation site. Other neuromodulation treatments may cause mild adverse effects such as tingling, lightheadedness, and muscle spasms. Serious complications are uncommon but can include hardware malfunctions and, in very rare cases, seizures.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for spinal cord injury that directly engage pro-plasticity neuromodulatory circuits like Vagus Nerve Stimulation (VNS). VNS is currently being studied for its potential to enhance recovery of motor and sensory function in SCI by engaging neural plasticity during rehabilitation exercises. Other treatments for SCI focus on managing symptoms and improving quality of life, but VNS represents a novel approach that is still under investigation.

What other types of research exist?

Promising novel alternatives to Vagus Nerve Stimulation for spinal cord injury patients include: 1) Targeted Plasticity Therapy (TPT), which uses brief pulses of vagus nerve stimulation during rehabilitation exercises to enhance neural plasticity and recovery of motor and sensory function. 2) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing pain intensity and could potentially be adapted for neuromodulatory purposes in SCI. 3) Remote electrical neuromodulation, which involves nonpainful electrical skin stimulation and has shown promise in reducing acute pain, potentially adaptable for SCI rehabilitation.

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Neuromodulation

Vagus Nerve Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Rita Hamilton, DO

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

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

Must have

Must demonstrate some residual upper limb and hand movement in either arm

Adult, aged 18-64

Must not have

Clinical complications that hinder or contraindicate the surgical procedure

Excessive scar tissue marking implantation unsafe (evident at surgery)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 1 through study follow-up, approximately two years from the date of implant

Awards & highlights

Summary

This trial tests a new treatment that sends small electrical pulses to a nerve in the neck during physical therapy to help people with spinal cord injuries regain movement and feeling in their arms. The treatment helps the brain and spinal cord 'rewire' themselves, making recovery more effective.

Who is the study for?

Adults aged 18-64 with a spinal cord injury from trauma at least one year ago, who have some upper limb movement and are in good health. Candidates must be able to follow the study protocol and agree to VNS implantation surgery. Excluded are those with conditions affecting rehabilitation, cognitive deficits preventing informed consent, recent syncope or dysphagia, non-English speakers, pregnant or lactating individuals, substance abusers, participants in other trials, and those with significant medical issues.

What is being tested?

The trial is testing vagus nerve stimulation (VNS) delivered by a new device during rehabilitation exercises for improving motor function in people with spinal cord injuries. It's a double-blind study where half of the participants will receive active VNS and the other half a placebo while undergoing training sessions.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, voice changes due to nerve stimulation, throat pain or tingling sensation during activation of the device. More serious risks could involve surgical complications or adverse reactions to electrical stimulation.

Eligibility Criteria

Inclusion Criteria

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

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I can move my arms and hands a little.

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I am between 18 and 64 years old.

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I have a first-time cervical spinal cord injury with some motor function, graded B, C, or D.

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I have a first-time cervical spinal cord injury with some motor function, graded B, C, or D.

Exclusion Criteria

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

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I have health issues that make surgery risky or not possible.

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I do not have excessive scar tissue that makes surgery unsafe.

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I have significant brain injuries.

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I have had or currently have vagus nerve stimulation treatment.

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I currently have active cancer.

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I can understand and consent to the study on my own.

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I have had surgery on the front of my neck and a check-up shows no vocal cord nerve damage.

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I have serious health issues that could make surgery or anesthesia very risky.

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I have had recent trouble swallowing.

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I have fainted recently.

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I have serious circulation issues like blood clots or swelling in my limbs.

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I have a spinal cord injury from a sharp object, gunshot, or was born with it.

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I am not on any treatments that would affect VNS therapy.

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I do not have severe breathing problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 1 through study follow-up, approximately two years from the date of implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 1 through study follow-up, approximately two years from the date of implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 1 through study follow-up, approximately two years from the date of implant 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 Adverse Events [Device Safety]

Secondary study objectives

Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)

Range of Motion, Articular

Restore System Feasibility during Rehabilitation

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Immediate Start Vagus Nerve Stimulation groupExperimental Treatment1 Intervention

The Immediate Start VNS group will receive rehabilitation and active stimulation for 18 in-office sessions over the course of approximately 6 weeks during phase 1. For phase 2, all subjects will be provided the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately 6 weeks. Participants that elect to continue in the open-label extension will be assessed approximately 1 week after the conclusion of the additional 18 sessions of therapy.

Group II: Delayed Start Vagus Nerve Stimulation groupPlacebo Group1 Intervention

The Delayed Start VNS group will receive equivalent rehabilitation with placebo stimulation for 18 in-office sessions over the course of approximately 6 weeks during phase 1. For phase 2, all subjects will be provided the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately 6 weeks. Participants that elect to continue in the open-label extension will be assessed approximately 1 week after the conclusion of the additional 18 sessions of therapy.

0 / 18Eligibility 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

Common treatments for spinal cord injury (SCI) include physical rehabilitation, pharmacologic agents, and neuromodulation techniques such as Vagus Nerve Stimulation (VNS). VNS works by delivering brief pulses to the vagus nerve, which engages pro-plasticity neuromodulatory circuits, enhancing neural plasticity and promoting recovery of motor and sensory functions. This is crucial for SCI patients as it can lead to significant improvements in functional outcomes and quality of life by facilitating the reorganization and strengthening of neural connections in the brain and spinal cord.

Left vagus nerve stimulation suppresses experimentally induced pain.