Effects of External Ear Stimulation on Pain Perception and Mood
National Center for Complementary and Integrative Health (NCCIH)
Summary
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
Description
This double-blind, randomized, controlled, cross-over study on healthy participants will evaluate the perceptual differences of pain and changes in mood in response to peripheral nerve stimulation over two regions of the left external ear. A series of short and long duration heat stimuli will be applied to the participants forearms and they will be asked to rate their current mood state, the intensity of the pain, and whether it was pleasant or unpleasant. The series of heat stimuli will be applied before, during, and after mild electrical stimulation of the left external ear using a commercia…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
* INCLUSION CRITERIA: All subjects must be: 1. between 18 and 50 years old. 2. fluent in English. 3. able to provide written informed consent. EXCLUSION CRITERIA: Overall exclusion criteria for the study 1. Unable to comply with study procedures or visits (including inability to schedule the second session within 10 business days of the first session). 2. Is pregnant or breastfeeding. 3. Has ears with indiscernible structures (e.g., cymba conchae, earlobe) due to congenital malformations, accidents, or physical alterations (e.g., "gauge", cartilage piercing). 4. Has a dermatological condi…
Interventions
- DeviceThe Twin Stim Plus, 3rd Edition
Mild transcutaneous electrical stimulation will be applied to the cymba conchae of the left ear on day 1 and the left earlobe on day 2 (or vice versa) using a commercially available TENS unit (transcutaneous electrical nerve stimulator) attached to a pair of silver electrodes.
- DeviceMedoc Pathway System
Device used to apply Thermal stimulation to both arms.
Location
- National Institutes of Health Clinical CenterBethesda, Maryland