taVNS Cold Pressor

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Brain Stimulation; taVNS

Treatments: Device: Sham taVNS; Device: Active taVNS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05254080

00113453

5R25DA020537-15 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ages 18-65 years
• English speaking
• Non-treatment-seeking community members

Exclusion criteria

• Diagnosis of COVID-19 in the past 14 days
• Facial or ear pain or recent ear trauma.
• Metal implant devices in the head, heart or neck.
• History of brain stimulation or other brain surgery.
• History of myocardial infarction or arrhythmia, bradycardia.
• Use of B-blockers, antiarrhythmic medication (sodium/potassium/calcium-channel blockers), or blood pressure medications.
• Active respiratory disorder.
• Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
• Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
• Individuals suffering from frequent/severe headaches.
• Individuals with a reported history of any mental health disorder or taking any psychotropic medications.
• Moderate to severe alcohol or substance use disorder.
• Pregnancy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Active taVNS then Sham taVNS

Experimental group

Description:

Participants will receive active then sham (placebo) ear stimulation.

Treatment:

Device: Active taVNS

Device: Sham taVNS

Sham taVNS then Active taVNS

Experimental group

Description:

Participants will receive sham (placebo) then active ear stimulation.

Treatment:

Device: Active taVNS

Device: Sham taVNS