Ear zaps might tame pain – but Don't get excited yet
NCT ID NCT02821741
First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 8 times
Summary
This study tests whether stimulating a nerve in the left ear with a mild electric current can change how healthy people perceive pain. Over two sessions, 76 volunteers will receive stimulation either on the vagus nerve area or a non-nerve spot, while a heat probe is applied to their arm. Researchers will also track mood and vital signs to see if mood influences pain. It's a small, early study in healthy people, so it won't directly lead to a new treatment yet.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous electrical nerve stimulation (TENS) device
- What this could lead to
- If successful, this could point toward a non-drug way to manage pain by stimulating the vagus nerve through the ear.
- What could go wrong
- This is a small, early-phase study in healthy volunteers, not patients. Results may not apply to real pain conditions, and the effect may be too weak to be useful.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
70 people
The number who actually took part.
- Started
-
Oct 2016
- Finished
-
Sep 2026
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: All subjects must be: 1. between 18 and 50 years old. 2. fluent in English. 3. able to provide written informed consent. EXCLUSION CRITERIA: Overall exclusion criteria for the study 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. Exclusion criteria for individual study session\* 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pain in healthy participants are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States