RECRUITING

Effects of External Ear Stimulation on Pain Perception and Mood

Conditions

Pain in Healthy Participants Sensory Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Effects of External Ear Stimulation on Pain Perception and Mood

Quick Facts

Study Start:2016-10-18

Study Completion:2025-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02821741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. between 18 and 50 years old. 2. fluent in English. 3. able to provide written informed consent.	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 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. 5. Women who consume more than 7 alcoholic beverages per week, and men who consume more than 14 drinks per week. 6. Has a current chronic pain condition or has had chronic pain in the past year (painful condition lasting more than six months). 7. Has a major medical condition, such as kidney, liver, cardiovascular, autonomic, pulmonary, or neurological problems (e.g., epilepsy) or a chronic systemic disease (e.g., diabetes). 8. Has or had psychiatric disorders such as major depression, major anxiety-related problems, post-traumatic stress syndrome, bipolar disorder, psychosis, or alcohol or substance abuse disorders as identified by the MINI International Neuropsychiatric Interview questionnaire, which will be administered as part of the screening procedure. 9. Has a medical condition potentially affecting cardiac functioning (e.g. arrhythmias, bradycardia \[\<60 beats per min; determined during screening\]) or Raynaud s Disease or other medical condition affecting peripheral vascular sensitivity. 10. Is actively taking medications that are known to interfere with current measurements of pain or autonomic function. These include but are not limited to: opioids, antidepressants (such as tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors), anticonvulsants (including gabapentin and pregabalin), and blood pressure medications (including beta-blockers, calcium channel blockers, and ACE inhibitors). Participants who have used such medications in the last three months must have ceased taking them for at least one month or three medication half-lives (whichever is longer) in order to be included. 11. Baseline heat pain threshold exceeds 46 degrees C (to be determined after consent). 12. Has ever had acupuncture in or around any area of the ears. 13. NIH employees are subordinates, relatives, or co-workers of the investigators, or NCCIH DIR employees. 1. Has consumed alcohol within 24 hours, shows signs of alcohol withdrawal syndrome, or has behavioral signs of intoxication. 2. Has exercised or eaten within two hours of testing session. 3. Used nicotinic substances (e.g., tobacco, gum, 'e-cigarette') within 2 hours of testing. 4. Used topical pain-relieving creams in the testing area (e.g. methylsalicylate, capsaicin) within 24 hours of testing. 5. Used non-steroidal anti-inflammatory drugs (NSAIDS, e.g. aspirin, ibuprofen), acetaminophen, naproxen, sumatriptan within 3 days of testing. * To be determined during the pre-session screening. Participants that cannot refrain from these activities may have their session rescheduled up to two times. If the participant is found non-compliant during the second rescheduled appointment, he or she will be excluded from the study.

Inclusion Criteria

Exclusion Criteria

1. between 18 and 50 years old.
2. fluent in English.
3. able to provide written informed consent.

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 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.
5. Women who consume more than 7 alcoholic beverages per week, and men who consume more than 14 drinks per week.
6. Has a current chronic pain condition or has had chronic pain in the past year (painful condition lasting more than six months).
7. Has a major medical condition, such as kidney, liver, cardiovascular, autonomic, pulmonary, or neurological problems (e.g., epilepsy) or a chronic systemic disease (e.g., diabetes).
8. Has or had psychiatric disorders such as major depression, major anxiety-related problems, post-traumatic stress syndrome, bipolar disorder, psychosis, or alcohol or substance abuse disorders as identified by the MINI International Neuropsychiatric Interview questionnaire, which will be administered as part of the screening procedure.
9. Has a medical condition potentially affecting cardiac functioning (e.g. arrhythmias, bradycardia \[\<60 beats per min; determined during screening\]) or Raynaud s Disease or other medical condition affecting peripheral vascular sensitivity.
10. Is actively taking medications that are known to interfere with current measurements of pain or autonomic function. These include but are not limited to: opioids, antidepressants (such as tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors), anticonvulsants (including gabapentin and pregabalin), and blood pressure medications (including beta-blockers, calcium channel blockers, and ACE inhibitors). Participants who have used such medications in the last three months must have ceased taking them for at least one month or three medication half-lives (whichever is longer) in order to be included.
11. Baseline heat pain threshold exceeds 46 degrees C (to be determined after consent).
12. Has ever had acupuncture in or around any area of the ears.
13. NIH employees are subordinates, relatives, or co-workers of the investigators, or NCCIH DIR employees.
1. Has consumed alcohol within 24 hours, shows signs of alcohol withdrawal syndrome, or has behavioral signs of intoxication.
2. Has exercised or eaten within two hours of testing session.
3. Used nicotinic substances (e.g., tobacco, gum, 'e-cigarette') within 2 hours of testing.
4. Used topical pain-relieving creams in the testing area (e.g. methylsalicylate, capsaicin) within 24 hours of testing.
5. Used non-steroidal anti-inflammatory drugs (NSAIDS, e.g. aspirin, ibuprofen), acetaminophen, naproxen, sumatriptan within 3 days of testing.
* To be determined during the pre-session screening. Participants that cannot refrain from these activities may have their session rescheduled up to two times. If the participant is found non-compliant during the second rescheduled appointment, he or she will be excluded from the study.

Contacts and Locations

Study Contact

Hayley Owens

CONTACT

(301) 451-2413

hayley.owens@nih.gov

Eleni Frangos, Ph.D.

CONTACT

(202) 873-4061

eleni.frangos@nih.gov

Principal Investigator

Eleni Frangos, Ph.D.

PRINCIPAL_INVESTIGATOR

National Center for Complementary and Integrative Health (NCCIH)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Eleni Frangos, Ph.D., PRINCIPAL_INVESTIGATOR, National Center for Complementary and Integrative Health (NCCIH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-10-18

Study Completion Date2025-03-30

Study Record Updates

Study Start Date2016-10-18

Study Completion Date2025-03-30

Terms related to this study

Keywords Provided by Researchers

Sensory Stimulation

Additional Relevant MeSH Terms

Pain in Healthy Participants