Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of External Ear Stimulation on Pain Perception and Mood

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02821741
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Center for Complementary and Integrative Health (NCCIH) )

Brief 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


Condition or disease
Pain

Detailed 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 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 76 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
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



Primary Outcome Measures :
  1. The effect of tVNS on pain intensity compared to control stimulation [ Time Frame: Ongoing ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Eunice Chung (301) 827-0020 eunice.chung@nih.gov

Locations
Layout table for location information
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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Layout table for investigator information
Principal Investigator: Mary C Bushnell, Ph.D. National Center for Complementary and Integrative Health (NCCIH)

Additional Information:
Layout table for additonal information
Responsible Party: National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT02821741     History of Changes
Other Study ID Numbers: 160136
16-AT-0136
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: December 6, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Center for Complementary and Integrative Health (NCCIH) ):
Sensory Stimulation