Vagus Nerve Stimulation for Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn whether stimulating a nerve in the neck changes how much pain people feel. It also looks at whether this stimulation changes brain activity. The study is being done in healthy adults ages 18 to 70.
The nerve being studied is called the vagus nerve. It runs through the neck and connects to parts of the brain that handle pain. In this study, the nerve is stimulated from outside the body using a small device placed on the skin. There is no surgery, and nothing is implanted.
The main questions it aims to answer are: (1) Does stimulating the vagus nerve lower the pain people feel during a cold water test? (2) Does stimulating the vagus nerve change the electrical activity in the brain?
Researchers will compare pain ratings and brain activity under three conditions in the same person: no stimulation, real stimulation over the vagus nerve, and sham stimulation placed nearby on the neck. Sham stimulation feels similar but is not aimed at the nerve.
Participants will: (1) Come to one visit that lasts about 90 minutes, with no follow-up visits, (2) Wear a cap that records the brain's natural electrical signals for the whole visit, (3) Place both hands in cold water, about 39 degrees Fahrenheit, up to three times for up to 2 minutes each time, (4) Rate their pain after each cold water test, (5) Wear a stimulation device on the neck during two of the three cold water tests, (6) Not be told which of those two is the real stimulation until the visit is over.
Who Is on the Research Team?
David A Purger, MD, PhD
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
This trial is for healthy adults ages 18 to 70. People with certain medical conditions or sensitivities may not be able to join, but the main requirement is being generally healthy within this age range.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Active transcutaneous vagus nerve stimulation
Trial Overview
The study tests if stimulating the vagus nerve through the skin of the neck changes pain levels and brain activity during a cold water test. Each participant tries real stimulation, sham (fake) stimulation, and no stimulation in one visit.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during sham stimulation, then a third during active transcutaneous vagus nerve stimulation.
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during active transcutaneous vagus nerve stimulation, then a third during sham stimulation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
David A. Purger
Lead Sponsor
Indiana University Health
Collaborator
Indiana University Health Methodist Hospital
Collaborator
Purdue University
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.