This study explores the use of transcutaneous auricular vagus nerve stimulation (taVNS), a new form of neuromodulation which stimulates the ear. 24 healthy subjects without a past medical or psychiatric history will be recruited to participate in a phone screen followed by 1 lab visit. During the lab visit, subjects will participate twice in a validated stress induction technique called the cold pressor test, while concurrently receiving either active or sham taVNS. The cold pressor test consists of subjects placing their feet in an ice bath for a short period of time. Researchers will measure participant's heart rate while they receive taVNS (ear stimulation) and participate in the cold pressor test. Assessments of mood, anxiety, and stress will be collected at the beginning and end of the visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
24
Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
Medical University of South Carolina
Charleston, South Carolina, United States
Mean Heart Rate (Before CPT/taVNS)
Heart rate will be measured with EKG electrodes before concurrent stress test and ear stimulation.
Time frame: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Mean Heart Rate (During CPT/taVNS)
Heart rate will be measured with EKG electrodes during concurrent stress test and ear stimulation.
Time frame: During concurrent stress test and ear stimulation (average duration of 5 minutes)
Mean Heart Rate (After CPT/taVNS)
Heart rate will be measured with EKG electrodes after concurrent stress test and ear stimulation.
Time frame: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
Mean Score of Pain (Before CPT/taVNS)
Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) before concurrent stress test and ear stimulation.
Time frame: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Mean Score of Pain (During CPT/taVNS)
Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) during concurrent stress test and ear stimulation.
Time frame: During concurrent stress test and ear stimulation (average duration of 5 minutes)
Mean Score of Pain (After CPT/taVNS)
Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) after concurrent stress test and ear stimulation.
Time frame: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
Mean Score of Anxiety (Before CPT/taVNS)
Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) before concurrent stress test and ear stimulation.
Time frame: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Mean Score of Anxiety (During CPT/taVNS)
Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) during concurrent stress test and ear stimulation.
Time frame: During concurrent stress test and ear stimulation (average duration of 5 minutes)
Mean Score of Anxiety (After CPT/taVNS)
Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) after concurrent stress test and ear stimulation.
Time frame: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
Mean Score of Distress (Before CPT/taVNS)
Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) before concurrent stress test and ear stimulation.
Time frame: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Mean Score of Distress (During CPT/taVNS)
Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) during concurrent stress test and ear stimulation.
Time frame: During concurrent stress test and ear stimulation (average duration of 5 minutes)
Mean Score of Distress (After CPT/taVNS)
Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) after concurrent stress test and ear stimulation.
Time frame: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
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