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taVNSNCT05254080

taVNS Cold Pressor

A study testing Active taVNS in people with taVNS and Brain Stimulation, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
taVNS, Brain Stimulation
What is being tested?
Active taVNS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
1 Oct 2021to 20 Dec 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: 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.

Being tested
Active taVNS, Sham taVNS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active taVNSDevice

    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 taVNSDevice

    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.

Study groups in NCT05254080
Study groupRoleWhat they receive
Active taVNS then Sham taVNSExperimentalParticipants will receive active then sham (placebo) ear stimulation.
Receives: Device: Active taVNS; Device: Sham taVNS
Sham taVNS then Active taVNSExperimentalParticipants will receive sham (placebo) then active ear stimulation.
Receives: Device: Active taVNS; Device: Sham taVNS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Heart Rate (Before CPT/taVNS)

    Heart rate will be measured with EKG electrodes before concurrent stress test and ear stimulation.

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

  2. Mean Heart Rate (During CPT/taVNS)

    Heart rate will be measured with EKG electrodes during concurrent stress test and ear stimulation.

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

  3. Mean Heart Rate (After CPT/taVNS)

    Heart rate will be measured with EKG electrodes after concurrent stress test and ear stimulation.

    Measured: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)

Secondary outcomes (9)

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)

  4. 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.

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

  5. 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.

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

  6. 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.

    Measured: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)

  7. 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.

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

  8. 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.

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

  9. 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.

    Measured: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2022
  2. Study start1 Oct 2021
  3. Primary completion20 Dec 2021
  4. Study completion20 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254080
Sponsor's protocol ID
00113453
Other IDs
5R25DA020537-15
Status last verified
Jan 2024
First submitted
18 Jan 2022
Last updated
17 Jan 2024
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active taVNS in people with taVNS and Brain Stimulation, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Heart Rate (Before CPT/taVNS) (time frame: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05254080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.

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