taVNS Cold Pressor

Brain Stimulation Clinical Trial

Official title:

Assessing the Physiologic Effect of taVNS During a Cold Pressor Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05254080
• Other study ID #: 00113453
• Secondary ID: 5R25DA020537-15
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Stimulation
• taVNS

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Heart Rate (Before CPT/taVNS)	Heart rate will be measured with EKG electrodes before concurrent stress test and ear stimulation.	Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Primary	Mean Heart Rate (During CPT/taVNS)	Heart rate will be measured with EKG electrodes during concurrent stress test and ear stimulation.	During concurrent stress test and ear stimulation (average duration of 5 minutes)
Primary	Mean Heart Rate (After CPT/taVNS)	Heart rate will be measured with EKG electrodes after concurrent stress test and ear stimulation.	After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
Secondary	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.	Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Secondary	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.	During concurrent stress test and ear stimulation (average duration of 5 minutes)
Secondary	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.	After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
Secondary	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.	Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Secondary	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.	During concurrent stress test and ear stimulation (average duration of 5 minutes)
Secondary	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.	After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
Secondary	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.	Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Secondary	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.	During concurrent stress test and ear stimulation (average duration of 5 minutes)
Secondary	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.	After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)