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
This trial accepts healthy volunteersQualifiers
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
Crossover
Treatments tested in this trial
The Twin Stim Plus, 3rd Edition
DeviceMild 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.
Medoc Pathway System
DeviceDevice used to apply Thermal stimulation to both arms.
Treatment groups
Trial outcomes
Primary outcomes
The difference in pain ratings collected for each subject during the two types of left ear stimulation (cymba conchae and earlobe).
See measures
Secondary outcomes
The effect of tVNS on pain threshold, pain unpleasantness, and mood as measured by visual analogue scales (VAS).
See measures
Mood and anxiety, as measured by questionnaires taken at the beginning and end of both study sessions.
See measures
Autonomic measures will be analyzed to determine whether tVNS has an effect on heart rate variability.
See measures
Sponsors and contacts
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