taVNS Cold Pressor

January 12, 2024 updated by: Christopher Austelle, Medical University of South Carolina

Assessing the Physiologic Effect of taVNS During a Cold Pressor Test

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active taVNS then Sham taVNS
Participants will receive active then sham (placebo) ear stimulation.
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).
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.
Experimental: Sham taVNS then Active taVNS
Participants will receive sham (placebo) then active ear stimulation.
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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Heart Rate (Before CPT/taVNS)
Time Frame: 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.
Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Mean Heart Rate (During CPT/taVNS)
Time Frame: 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.
During concurrent stress test and ear stimulation (average duration of 5 minutes)
Mean Heart Rate (After CPT/taVNS)
Time Frame: 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.
After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Score of Pain (Before CPT/taVNS)
Time Frame: 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.
Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Mean Score of Pain (During CPT/taVNS)
Time Frame: 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.
During concurrent stress test and ear stimulation (average duration of 5 minutes)
Mean Score of Pain (After CPT/taVNS)
Time Frame: 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.
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)
Time Frame: 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.
Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Mean Score of Anxiety (During CPT/taVNS)
Time Frame: 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.
During concurrent stress test and ear stimulation (average duration of 5 minutes)
Mean Score of Anxiety (After CPT/taVNS)
Time Frame: 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.
After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
Mean Score of Distress (Before CPT/taVNS)
Time Frame: 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.
Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Mean Score of Distress (During CPT/taVNS)
Time Frame: 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.
During concurrent stress test and ear stimulation (average duration of 5 minutes)
Mean Score of Distress (After CPT/taVNS)
Time Frame: 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.
After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher W Austelle, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00113453
  • 5R25DA020537-15 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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