NCT05254080

taVNS Cold Pressor

Assessing the Physiologic Effect of taVNS During a Cold Pressor Test

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• taVNS
• Brain Stimulation

Interventions

Type	Name	Description
DEVICE	Active taVNS	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).
DEVICE	Sham taVNS	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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2021-12-20
• Completion: 2021-12-20
• First posted: 2022-02-24
• Last updated: 2024-01-17
• Results posted: 2023-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study