taVNS Cold Pressor

Not Applicable

Completed

Conditions: Brain Stimulation
taVNS

Interventions: Device: Active taVNS
Device: Sham taVNS

Registration Number: NCT05254080

Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active taVNS then Sham taVNS	Sham taVNS	Participants will receive active then sham (placebo) ear stimulation.
Sham taVNS then Active taVNS	Sham taVNS	Participants will receive sham (placebo) then active ear stimulation.
Active taVNS then Sham taVNS	Active taVNS	Participants will receive active then sham (placebo) ear stimulation.
Sham taVNS then Active taVNS	Active taVNS	Participants will receive sham (placebo) then active ear stimulation.

Primary Outcome Measures

Name	Time	Method
Mean Heart Rate (Before CPT/taVNS)	Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)	Heart rate will be measured with EKG electrodes before concurrent stress test and ear stimulation.
Mean Heart Rate (After CPT/taVNS)	After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)	Heart rate will be measured with EKG electrodes after concurrent stress test and ear stimulation.
Mean Heart Rate (During CPT/taVNS)	During concurrent stress test and ear stimulation (average duration of 5 minutes)	Heart rate will be measured with EKG electrodes during concurrent stress test and ear stimulation.

Secondary Outcome Measures

Name	Time	Method
Mean Score of Anxiety (During CPT/taVNS)	During concurrent stress test and ear stimulation (average duration of 5 minutes)	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.
Mean Score of Pain (Before CPT/taVNS)	Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)	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.
Mean Score of Pain (After CPT/taVNS)	After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)	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.
Mean Score of Pain (During CPT/taVNS)	During concurrent stress test and ear stimulation (average duration of 5 minutes)	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.
Mean Score of Anxiety (Before CPT/taVNS)	Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)	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.
Mean Score of Anxiety (After CPT/taVNS)	After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)	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.
Mean Score of Distress (Before CPT/taVNS)	Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)	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.
Mean Score of Distress (During CPT/taVNS)	During concurrent stress test and ear stimulation (average duration of 5 minutes)	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.
Mean Score of Distress (After CPT/taVNS)	After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)	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.