Effects of Transcutaneous Vagus Nerve Stimulation on Pain and Brain Activity in Healthy Adults

Conditions

• Acute Pain
• Healthy Adult Participants
• Pain Perception

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Accepted

Interventions

• Active transcutaneous vagus nerve stimulation — DEVICE
  Stimulation applied over the cervical branch of the vagus nerve, anterior to the sternocleidomastoid along the carotid sheath. Pulse width 200 microseconds, frequency 30 Hz, rectangular monophasic waveform, intensity titrated between 17.8 and 39.5 volts to a mild tingling sensation below the threshold of discomfort. Stimulation is maintained for 20 minutes before the cold pressor test and continues throughout it.
• Sham transcutaneous vagus nerve stimulation — DEVICE
  Identical device, parameters, and duration as the active condition, differing only in placement. The device is positioned slightly posterior on the neck, away from the cervical branch of the vagus nerve.
• Cold pressor test — OTHER
  Immersion of both hands up to the wrist in water maintained at 4 degrees Celsius with ice for up to two minutes or as long as tolerated. Performed three times per participant: once with no stimulation, once during active stimulation, and once during sham stimulation.

Study Details

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.

Key Dates

First listed

Sep 18, 2026

Start date

Sep 30, 2026

Status verified

Sep 2026

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Active Stimulation First, Then Sham
  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.
• Experimental: Sham Stimulation First, Then Active
  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.

Primary Outcome Measure

Pain intensity measured by the Numerical Pain Rating Scale [ Time Frame: Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes. ]

Central Contacts

• Caliel Hines
  317-963-7010
  [email protected]
• Marissa Lowe
  [email protected]

Locations (1)

Find similar trials in Indianapolis, IN

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