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Completed

NCT Number: NCT05254080

taVNS Cold Pressor

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.

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Key information

Conditions

taVNS Brain Stimulation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Assessing the Physiologic Effect of taVNS During a Cold Pressor Test

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2022
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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