What is the mechanism of action of this treatment?

Common treatments for spinal cord injury (SCI) include neuromodulation techniques such as Vagus Nerve Stimulation (VNS) and Transcutaneous Electrical Nerve Stimulation (TENS). VNS works by delivering electrical impulses to the vagus nerve, which can enhance neuroplasticity and improve rehabilitation outcomes by modulating the central nervous system's response to injury. TENS provides symptomatic relief by altering pain perception through continuous electrical impulses delivered via surface electrodes. These treatments are crucial for SCI patients as they can potentially improve motor function, reduce pain, and enhance overall quality of life by leveraging the body's own neural pathways to promote recovery and adaptation.

What side effects are associated with this type of intervention?

Common treatments for spinal cord injury involving electrical stimulation include Vagus Nerve Stimulation (VNS) and Transcutaneous Electrical Nerve Stimulation (TENS). VNS is generally well-tolerated but can cause mild side effects such as a warm sensation, numbness, redness, itching, tingling, muscle spasms, and localized pain. TENS, used for pain management, may cause skin irritation, tingling, and discomfort at the site of electrode placement. Both treatments have a low incidence of serious adverse events.

What prior FDA approvals exist?

The FDA has approved various neuromodulation devices for different medical conditions, but specific approvals for vagus nerve stimulation (VNS) in the treatment of spinal cord injury are not detailed in the provided context. VNS has been studied for its potential to enhance rehabilitation outcomes in spinal cord injury patients, focusing on improving upper extremity function. While VNS is approved for other conditions such as epilepsy and depression, its application in spinal cord injury remains investigational. Broader neuromodulation techniques, including transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS), have shown promise in related areas but are not specifically approved for spinal cord injury rehabilitation.

What other types of research exist?

Promising, novel alternatives to Vagus Nerve Stimulation for spinal cord injury patients include transcutaneous supraorbital nerve stimulation, remote electrical neuromodulation, and transcranial magnetic stimulation (TMS). These methods have shown efficacy in other neurological conditions and may offer new avenues for enhancing rehabilitation outcomes in spinal cord injury patients.

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Vagus Nerve Stimulation

Vagus Nerve Stimulation + Rehabilitation for Spinal Cord Injury

N/A

Recruiting

Led By Radha Korupolu

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

Summary

This trial uses a device that sends electrical signals to a nerve in the neck while patients do exercises. It targets adults with partial spinal cord injuries in the neck area who struggle with arm and hand movement. The electrical signals may help improve how the brain and nerves respond to exercise, aiding recovery.

Who is the study for?

This trial is for individuals at least 12 months post-traumatic cervical spinal cord injury (C8 and above), with some upper limb movement, like pinching. They must meet surgical criteria for VNS implantation. Excluded are those with non-traumatic SCI, vocal cord issues, significant brain injuries, prior vagus nerve damage, certain medications affecting neurotransmitters, other complicating conditions or surgeries, medical or mental instability, or pregnancy.

What is being tested?

The study tests the safety and effectiveness of pairing vagus nerve stimulation (VNS) with arm rehabilitation to improve upper extremity function in people with cervical spinal cord injury. Participants will receive either active VNS or a sham procedure alongside their rehabilitation exercises.

What are the potential side effects?

Potential side effects may include discomfort from the VNS device itself and typical risks associated with any surgical implantation procedure. Specific side effects related to VNS can vary but might involve changes in voice tone or involuntary throat sensations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety as assessed by number of subjects with post surgical complications

Secondary study objectives

Change in Depression as assessed by the Patient Health Questionnaire (PHQ-8)

Pain

Change in capability of using arms and hands as assessed by the Capabilities of Upper Extremity Questionnaire (CUE-Q)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment groupExperimental Treatment2 Interventions

Participants in the treatment group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with paired VNS over six weeks. Followed by 90 days home exercise program.

Group II: Control GroupPlacebo Group2 Interventions

Participants in the control group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with sham VNS over six weeks. Followed by 90 days home exercise program.

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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 neuromodulation techniques such as Vagus Nerve Stimulation (VNS) and Transcutaneous Electrical Nerve Stimulation (TENS). VNS works by delivering electrical impulses to the vagus nerve, which can enhance neuroplasticity and improve rehabilitation outcomes by modulating the central nervous system's response to injury. TENS provides symptomatic relief by altering pain perception through continuous electrical impulses delivered via surface electrodes. These treatments are crucial for SCI patients as they can potentially improve motor function, reduce pain, and enhance overall quality of life by leveraging the body's own neural pathways to promote recovery and adaptation.

Efficacy of pulsed low-intensity electric neuromuscular stimulation in reducing pain and disability in patients with myofascial syndrome.