Effects of External Ear Stimulation on Pain Perception and Mood

Conditions

• Pain in Healthy Participants

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• The Twin Stim Plus, 3rd Edition — DEVICE
  Mild transcutaneous electrical stimulation will be applied to the cymba conchae of the left ear on day 1 and the left earlobe on day 2 (or vice versa) using a commercially available TENS unit (transcutaneous electrical nerve stimulator) attached to a pair of silver electrodes.
• Medoc Pathway System — DEVICE
  Device used to apply Thermal stimulation to both arms.

Study Details

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

Key Dates

Start date

Oct 18, 2016

Status verified

Jan 2026

Primary completion

Mar 30, 2027

Completion

Mar 30, 2027

Study Design

Enrollment

76 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Cymba Conchae
  Mild electrical stimulation is applied to the cymba conchae of the left ear, and thermal stimulation is applied to the arms.
• Active Comparator: Ear Lobe
  Mild electrical stimulation is applied to the earlobe of the left ear, and thermal stimulation is applied to the arms.

Primary Outcome Measure

The difference in pain ratings collected for each subject during the two types of left ear stimulation (cymba conchae and earlobe). [ Time Frame: End of study ]

Central Contacts

• Hayley A Owens
  (301) 451-2413
  [email protected]
• Alisa J Johnson
  (240) 603-0537
  [email protected]

Locations (1)

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