Effects of External Ear Stimulation on Pain Perception and Mood
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|ClinicalTrials.gov Identifier: NCT02821741|
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : April 12, 2019
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.
To study the effects of mood and vagus nerve stimulation on the experience of pain.
Healthy people ages 18 and older who are fluent in English
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
A heat probe on the forearm. The temperature will be increased until it is painful
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
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
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||76 participants|
|Official Title:||Effects of External Ear Stimulation on Pain Perception and Mood|
|Study Start Date :||June 29, 2016|
|Estimated Primary Completion Date :||March 30, 2020|
|Estimated Study Completion Date :||March 30, 2020|
- The effect of tVNS on pain intensity compared to control stimulation [ Time Frame: Ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821741
|Contact: Eunice Chung||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Mary C Bushnell, Ph.D.||National Center for Complementary and Integrative Health (NCCIH)|