taVNS Cold Pressor

NCT ID: NCT05254080

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2021-12-20

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.

Conditions

taVNS; Brain Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Active taVNS then Sham taVNS

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

Group Type: EXPERIMENTAL

Active taVNS

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Sham taVNS then Active taVNS

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

Group Type: EXPERIMENTAL

Active taVNS

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Christopher Austelle

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher W Austelle, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R25DA020537-15

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00113453

Identifier Type: -

Identifier Source: org_study_id