Effects of External Ear Stimulation on Pain Perception and Mood
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 12/20/2018 |
| Start Date: | June 29, 2016 |
| End Date: | March 30, 2019 |
| Contact: | Eunice Chung |
| Email: | eunice.chung@nih.gov |
| Phone: | (301) 827-0020 |
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
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
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 commercially available TENS unit.
There are two study sessions. Session 1 involves eligibility screening, a brief practice
session, followed by the testing session. In Session 2 (no more than 7 days later), the
testing session will be repeated with the exception of the location of ear stimulation. Up to
76 people, ages 18-50 years old, will be enrolled in the study.
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 commercially available TENS unit.
There are two study sessions. Session 1 involves eligibility screening, a brief practice
session, followed by the testing session. In Session 2 (no more than 7 days later), the
testing session will be repeated with the exception of the location of ear stimulation. Up to
76 people, ages 18-50 years old, will be enrolled in the study.
- INCLUSION CRITERIA:
You may qualify if are:
- between 18 and 50 years old
- fluent in English
- in good health
EXCLUSION CRITERIA:
You may not qualify if you:
- have a major medical condition
- have a psychiatric condition (including alcohol or substance abuse disorders)
- suffer from chronic pain
- are pregnant or breast-feeding
- have an ear malformation
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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