Vagus Nerve Stimulation for Pain

CH
ML
Overseen ByMarissa Lowe
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: David A. Purger
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?

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?

DA

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

Willing and able to provide written informed consent in English
Healthy with no history of chronic medical, neurological, or psychiatric conditions
I am between 18 and 70 years old.
See 2 more

Exclusion Criteria

Pregnancy
I have an irregular heartbeat.
Significant acute or chronic neurologic illness that could compromise participant safety, limit ability to complete the study, or compromise study objectives as judged by Principal Investigator
See 6 more

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

Group I: Sham Stimulation First, Then ActiveExperimental Treatment3 Interventions
Group II: Active Stimulation First, Then ShamExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

David A. Purger

Lead Sponsor

Indiana University Health

Collaborator

Trials
35
Recruited
18,500+

Indiana University Health Methodist Hospital

Collaborator

Trials
4
Recruited
5,300+

Purdue University

Collaborator

Trials
239
Recruited
72,200+