taVNS Cold Pressor

NCT05254080 | Completed Results FDA Device

• 2 other identifiers: 001134535R25DA020537-15
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (9)

• Mean Score of Pain (Before CPT/taVNS)

  Baseline (up to 10 minutes prior to 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)

• 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)

• Mean Score of Anxiety (Before CPT/taVNS)

  Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)

• Mean Score of Anxiety (During CPT/taVNS)

  During concurrent stress test and ear stimulation (average duration of 5 minutes)

Study Arms (2)

Active taVNS then Sham taVNS

EXPERIMENTAL

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

Device: Active taVNS; Device: Sham taVNS

Sham taVNS then Active taVNS

EXPERIMENTAL

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

Device: Active taVNS; Device: Sham taVNS

Interventions

Active taVNS 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).

Active taVNS then Sham taVNS; Sham taVNS then Active taVNS

Sham taVNS 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.

Active taVNS then Sham taVNS; Sham taVNS then Active taVNS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Results Point of Contact

• Title: Dr. Christopher W. Austelle
• Organization: Medical University of South Carolina

austelle@musc.edu

843-792-2872

Study Officials

• Christopher W Austelle, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 24, 2022
• Study Start: October 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 17, 2024
• Results First Posted: September 8, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)