Vagus Nerve Stimulation for Neuropathic Pain

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Overseen ByJoy Jiang
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Must be taking: Anti-inflammatory, pain, depression
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with spinal cord injuries experiencing ongoing nerve pain. It employs a device called Transcutaneous Auricular Vagus Nerve Stimulation, which sends gentle electrical signals to an ear area connected to the vagus nerve, potentially easing pain. Participants will receive either the actual treatment or a placebo to determine any differences. The trial seeks individuals with spinal cord injuries who experience nerve pain and have not changed their pain or depression medication in the last six weeks. The primary goals are to assess the treatment's safety, adherence, and effectiveness in reducing pain. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to new pain management solutions.

Will I have to stop taking my current medications?

You can continue taking your current medications as long as they have been stable for at least 6 weeks. If your medication dose has changed recently, you may not be eligible for the trial.

What prior data suggests that this transcutaneous auricular vagus nerve stimulation is safe for adults with spinal cord injury and neuropathic pain?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe. Studies have found that most side effects are mild and temporary. The most common issue, minor skin irritation where the device contacts the skin, occurs in about 8.6% of users but usually resolves quickly.

The available data does not link any serious side effects directly to taVNS. Participants have tolerated the treatment well, even with long-term use. Notably, taVNS is under study for its potential to reduce pain and improve quality of life, with promising results so far.12345

Why are researchers excited about this trial?

Unlike standard treatments for neuropathic pain, which often include medications like anticonvulsants and antidepressants, transcutaneous auricular vagus nerve stimulation (taVNS) offers a non-invasive approach. This treatment is unique because it targets the vagus nerve through stimulation delivered directly to the ear, specifically the cymba conchae. Researchers are excited about taVNS because it could provide pain relief without the side effects associated with many medications, offering a promising alternative for those who haven't found relief through traditional methods. Additionally, the sham comparator in the trial helps ensure the observed effects are truly due to vagus nerve activation, enhancing the credibility of the findings.

What evidence suggests that transcutaneous auricular vagus nerve stimulation is effective for neuropathic pain?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) may help manage pain in individuals with chronic pain conditions. This trial will assign participants to either an active taVNS group or a sham taVNS group. In one study, taVNS significantly reduced nerve pain in patients with head and neck cancers. Another study found that it relieved pain when combined with a common pain medication. Early data also suggest that taVNS can reduce nerve-related symptoms and improve heart rate variability, indicating better vagus nerve health. Additionally, animal studies have demonstrated that taVNS can greatly reduce pain from nerve injuries.36789

Are You a Good Fit for This Trial?

This trial is for adults (18+) with any type of spinal cord injury who currently have nerve pain. Participants must be on no medications or a stable dose of pain, anti-inflammatory, or depression meds for at least 6 weeks.

Inclusion Criteria

I have a spinal cord injury of any level or severity.
I am 18 years old or older.
I currently have nerve pain.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham transcutaneous auricular vagus nerve stimulation for 4 hours per day over a 30-day home-based intervention period

4 weeks
Twice weekly phone calls and/or study visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Auricular Vagus Nerve Stimulation

Trial Overview

The study tests whether using a device that stimulates the vagus nerve through the ear (taVNS) at home for 30 days can help reduce nerve pain after spinal cord injury. Some participants get real stimulation; others get a sham (inactive) version.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active taVNSExperimental Treatment1 Intervention
Group II: Sham taVNSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
678
Recruited
421,000+

Citations

Transcutaneous vagus nerve stimulation effects on chronic pain

This meta-analysis indicates that tVNS shows promise as an effective intervention for managing pain intensity in chronic pain conditions. We ...

Efficacy and Safety of Transcutaneous Auricular Vagus ...

Efficacy of transcutaneous auricular vagus nerve stimulation on radiotherapy-related neuropathic pain in patients with head and neck cancers (RELAX): ...

Efficacy and safety of transcutaneous auricular vagus ...

In this trial, taVNS for 7 days at the initial stage of pregabalin treatment resulted in significantly better pain relief in HNC survivors with moderate-to- ...

Effectiveness of Transcutaneous Auricular Vagal Nerve... ...

taVNS also significantly reduced the incidence of rebound pain (58% vs. 18%; P-value=0.001) and chronic postsurgical pain at 3 months (27% vs. 6%; P-value=0.018) ...

Feasibility of trancutaneous auricular vagus nerve ...

Preliminary data indicated a decrease in neuropathic symptoms and an increased heart rate variability (HRV) during active taVNS, suggesting ...

Efficacy and safety of transcutaneous auricular vagus ...

The most common adverse event (AE) related to taVNS was mild, transient local skin irritations at the electrode site (8.6% versus 1.7%, P = 0.21), and no ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40697962/

Efficacy and safety of transcutaneous auricular vagus ...

The most common adverse event (AE) related to taVNS was mild, transient local skin irritations at the electrode site (8.6% versus 1.7%, P = 0.21), and no ...

Transcutaneous Auricular Vagus Nerve Stimulation as a ...

Primary outcomes include feasibility, safety, adherence, acceptability, and blinding success. Exploratory outcomes include changes in ...

Transcutaneous vagus nerve stimulation effects on chronic...

This meta-analysis indicates that tVNS shows promise as an effective intervention for managing pain intensity in chronic pain conditions.