LearningNCT04812015
Learning and Ear Stimulation
A study testing transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes, taVNS 30 minutes and taVNS 45 minutes in people with Learning and taVNS, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study aims to determine how non-invasive ear stimulation affects learning. During this study, participants will be asked to complete surveys and come to a lab for about 2.5 hours. Researchers will measure brain waves and other body responses (heart rate), while while the ear is stimulated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes, taVNS 30 minutes and taVNS 45 minutes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2022to 1 Mar 2023
- 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
- English speaking
- Non-treatment-seeking community members who do not have a mental health diagnosis and individuals seeking treatment for an anxiety, mood, trauma-related, or obsessive-compulsive disorder.
- Treatment and non-treatment-seeking community members with anxiety, mood, trauma-related, or obsessive-compulsive disorder or symptoms.
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.
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- 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 lifetime evidence of severe psychiatric disorder (e.g., schizophrenia) or neurological disorder.
- 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
About this study
Official title: Optimizing Transdiagnostic Non-invasive Vagus Nerve Stimulation to Enhance Learning
This study aims to determine how non-invasive ear stimulation affects learning. During this study, participants will be asked to complete surveys and come to a lab for about 2.5 hours. Researchers will measure brain waves and other body responses (heart rate), while while the ear is stimulated. Participants also will be asked to complete computer tasks. Because brain activity will be measured, participants will be asked to come to the study with clean, dry hair. The study is at MUSC in Charleston. Participants will be compensated for their time. To be eligible, participants must be 18-65 years old, be able to commit 2.5 hours of time to the study, and be able to wear sensors on their hands, arms, and head and sit quietly at a computer.
There are some risks to completing this study. Some questions in the surveys ask about personal thoughts and feelings. The ear stimulation may cause tingling sensations or irritation around the ear.
There are no direct benefits to participants. This study will help researchers improve this ear stimulation as a treatment method.
- Being tested
- transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes, taVNS 30 minutes, taVNS 45 minutes, taVNS 60 minutes, taVNS 75 minutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutesDevice
Sham 60 minutes and taVNS active stimulation for 15 minutes
taVNS 30 minutesDevice
Sham 45 minutes and taVNS active stimulation for 30 minutes
taVNS 45 minutesDevice
Sham 30 minutes and taVNS active stimulation for 45 minutes
taVNS 60 minutesDevice
Sham 15 minutes and taVNS active stimulation for 60 minutes
taVNS 75 minutesDevice
Sham 0 minutes and taVNS active stimulation for 75 minutes
taVNS 0 minutesDevice
Sham taVNS 75 minutes
| Study group | Role | What they receive |
|---|---|---|
| Dose Group 1 | Other | Not described Receives: Device: transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes |
| Dose Group 2 | Other | Not described Receives: Device: taVNS 30 minutes |
| Dose Group 3 | Other | Not described Receives: Device: taVNS 45 minutes |
| Dose Group 4 | Other | Not described Receives: Device: taVNS 60 minutes |
| Dose Group 5 | Other | Not described Receives: Device: taVNS 75 minutes |
| Dose Group 6 | Other | Not described Receives: Device: taVNS 0 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in P300 Amplitude
Measured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 2 intervals during stimulation.
Measured: Measured at Baseline and last 10 minutes of stimulation, on average 65 minutes
Change in Heart Rate Variability
Measured: Baseline to end of Active Stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start6 Jul 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LearningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812015
- Sponsor's protocol ID
- Pro00107689
- Status last verified
- Jul 2025
- First submitted
- 19 Mar 2021
- Last updated
- 13 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Transdiagnostic Non-invasive Vagus Nerve Stimulation to Enhance Learning
- ClinicalTrials.gov ID
- NCT04812015
- Acronym / sponsor ID
- Pro00107689
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Posted 13 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine how non-invasive ear stimulation affects learning. During this study, participants will be asked to complete surveys and come to a lab for about 2.5 hours. Researchers will measure brain waves and other body responses (heart rate), while while the ear is stimulated. Participants also will be asked to complete computer tasks. Because brain activity will be measured, participants will be asked to come to the study with clean, dry hair. The study is at MUSC in Charleston. Participants will be compensated for their time. To be eligible, participants must be 18-65 years old, be able to commit 2.5 hours of time to the study, and be able to wear sensors on their hands, arms, and head and sit quietly at a computer.
There are some risks to completing this study. Some questions in the surveys ask about personal thoughts and feelings. The ear stimulation may cause tingling sensations or irritation around the ear.
There are no direct benefits to participants. This study will help researchers improve this ear stimulation as a treatment method.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose Group 1 | Other | Device: transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes |
| Dose Group 2 | Other | Device: taVNS 30 minutes |
| Dose Group 3 | Other | Device: taVNS 45 minutes |
| Dose Group 4 | Other | Device: taVNS 60 minutes |
| Dose Group 5 | Other | Device: taVNS 75 minutes |
| Dose Group 6 | Other | Device: taVNS 0 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- Non-treatment-seeking community members who do not have a mental health diagnosis and individuals seeking treatment for an anxiety, mood, trauma-related, or obsessive-compulsive disorder.
- Treatment and non-treatment-seeking community members with anxiety, mood, trauma-related, or obsessive-compulsive disorder or symptoms.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutesSham 60 minutes and taVNS active stimulation for 15 minutes | Device | Dose Group 1 |
| taVNS 30 minutesSham 45 minutes and taVNS active stimulation for 30 minutes | Device | Dose Group 2 |
| taVNS 45 minutesSham 30 minutes and taVNS active stimulation for 45 minutes | Device | Dose Group 3 |
| taVNS 60 minutesSham 15 minutes and taVNS active stimulation for 60 minutes | Device | Dose Group 4 |
| taVNS 75 minutesSham 0 minutes and taVNS active stimulation for 75 minutes | Device | Dose Group 5 |
| taVNS 0 minutesSham taVNS 75 minutes | Device | Dose Group 6 |
Primary outcome
Change in P300 Amplitude
Time frame: Measured at Baseline and last 10 minutes of stimulation, on average 65 minutes
Measured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 2 intervals during stimulation.
Change in Heart Rate Variability
Time frame: Baseline to end of Active Stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes, taVNS 30 minutes and taVNS 45 minutes in people with Learning and taVNS, 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 13 Aug 2025. 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 13 Aug 2025). 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?
Change in P300 Amplitude (time frame: Measured at Baseline and last 10 minutes of stimulation, on average 65 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2025.