Effects of External Ear Stimulation on Pain Perception and Mood

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorNational Center for Complementary and Integrative Health (NCCIH)

About this trial

Background:

The vagus nerve runs from the brain to many organs. Stimulating it can affect the experience of pain. The nerve can be stimulated on the surface of the left ear. Researchers want to study how this stimulation affects the perception of pain. They also want to study how mood affects the experience of pain.

Objective:

To study the effects of mood and vagus nerve stimulation on the experience of pain.

Eligibility:

Healthy people ages 18 and older who are fluent in English

Design:

Participants will be pre-screened with a 15-minute phone call.

Participants will have three 2-hour visits.

At the screening visit, participants will be screened with:

Medical and psychiatric history

Physical and psychological exams

Questionnaires about physical and psychiatric health and mood

Urine tests

A heat probe on the forearm. The temperature will be increased until it is painful

but tolerable.

Participants will have 2 testing sessions within 7 days. Before the testing, they cannot do the following:

Eat, use nicotine, or exercise for at least 2 hours

Drink alcohol for 24 hours

Take certain medicines for 3 days

Testing includes:

Urine drug screening

Left ear stimulation: In one session, the vagus nerve will be stimulated. In the other, an area

of the ear away from the vagus nerve will be stimulated. This will be done with mild electric

shocks that cause a tingling, pricking, or itchy feeling.

Heat applied to the forearm until it is painful but tolerable

Completing several forms on a computer or on paper about how they are feeling

Monitors on the chest and a finger clip to monitor heart, breathing, and blood pressure

Eligibility criteria

Qualifiers

between 18 and 50 years old.

fluent in English.

able to provide written informed consent.

Disqualifiers

Unable to comply with study procedures or visits (including inability to schedule the second session within 10 business days of the first session).

Is pregnant or breastfeeding.

Has ears with indiscernible structures (e.g., cymba conchae, earlobe) due to congenital malformations, accidents, or physical alterations (e.g., "gauge", cartilage piercing).

Has a dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous four weeks that might influence cutaneous sensibility.

Trial design

Treatments tested in this trial

  • The Twin Stim Plus, 3rd Edition
  • Medoc Pathway System

Treatment groups

76 Participants
are divided into 2 treatment groups