Auricular StimulationNCT06518356
Mastoid taVNS-fMRI
A study testing Transcutaneous Auricular Neurostimulation (tAN) in people with Auricular Stimulation, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to explore whether stimulating different outer parts of the ear using a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) will create different brain activation images. Investigators will recruit 24 healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Auricular Stimulation
- What is being tested?
- Transcutaneous Auricular Neurostimulation (tAN)
- 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
- 26 Aug 2024to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 18-65
- Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
Who cannot join
- Unable to speak in English.
- Contraindicated for MRI.
- Any current or recent untreated medical, neurological, or psychiatric conditions
- Metal implant devices in the head, heart or neck.
- History of brain surgery.
- History of myocardial infarction or arrhythmia, bradycardia.
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- 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.
- Participant has abnormal ear anatomy, skin irritation, or ear infection present
- Individuals suffering from frequent/severe headaches.
- Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
- 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 Institute of Psychiatry
Charleston, South Carolina, 29425
About this study
Official title: Investigating the Direct Brain Effects of Activating the Auricular Branch of the Vagus Nerve From the Cymba Concha or Mastoid Process: a Sham-controlled fMRI Study
The purpose of this study is to explore whether stimulating different outer parts of the ear using a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) will create different brain activation images. Investigators will recruit 24 healthy participants. The ear stimulation will be delivered while taking brain images using a magnetic resonance imaging (MRI) machine.
Read the detailed description
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that delivers electric stimulation to the auricular branch of the vagus nerve (ABVN). This technique has been demonstrated effective in the treatment of depression and addiction in previous studies.
Most previous applications of taVNS targeted the ABVN via the cymba conchae or tragus sites. The mastoid process (mastoid site) is an important dermatome innervated by the ABVN, but there is currently a lack of knowledge on how taVNS on the mastoid site affects brain activity and whether it differs from the effect of stimulating the cymba site.
In this proposed study, the investigators plan to explore whether delivering taVNS to the mastoid site and the cymba site can induce different patterns of brain activity. Ultimately, if successful, this project will not only deepen our knowledge in basic neuroscience but also have great value in clinical applications since the mastoid site is a much more accessible ABVN target compared to other sites.
- Conditions
- Auricular Stimulation
- Being tested
- Transcutaneous Auricular Neurostimulation (tAN)
- Keywords
- Healthy Volunteer Studies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Neurostimulation (tAN)Device
The intervention the investigators are studying is called transcutaneous auricular neurostimulation (tAN). tAN is simply electrical nerve stimulation administered at the ear which targets the auricular branch of the vagus nerve (ABVN) at the cymba conchae and mastoid process, and to a sham site (earlobe).
| Study group | Role | What they receive |
|---|---|---|
| Auricular Neurostimulation (Active 1) | Active comparator | •Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target
-Cymba stimulation (15Hz stimulation of cymba conchae) Receives: Device: Transcutaneous Auricular Neurostimulation (tAN) |
| Auricular Neurostimulation (Active 2) | Active comparator | •Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target
-Mastoid stimulation (15Hz stimulation of mastoid process) Receives: Device: Transcutaneous Auricular Neurostimulation (tAN) |
| Auricular Neurostimulation (Sham 1) | Sham comparator | •Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target
-Sham (15Hz stimulation of the earlobe) Receives: Device: Transcutaneous Auricular Neurostimulation (tAN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen level-dependent (BOLD) signal changes during stimulation relative to sham stimulation
taVNS will be administered to participants within the bore of the MRI scanner while the investigators acquire high-resolution functional neuroimaging. Both a general linear model and SNM approach will be used to examine BOLD signal changes during stimulation relative to rest blocks, comparing each of the 3 stimulation targets within- and between- subjects to identify any differences in brain activity during stimulation of the mastoid site compared to the cymba site and sham site.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start26 Aug 2024
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auricular StimulationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaolong Peng, Medical University of South Carolina
- Investigators
- Xiaolong Peng, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518356
- Sponsor's protocol ID
- Pro00137424
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Direct Brain Effects of Activating the Auricular Branch of the Vagus Nerve From the Cymba Concha or Mastoid Process: a Sham-controlled fMRI Study
- ClinicalTrials.gov ID
- NCT06518356
- Acronym / sponsor ID
- Pro00137424
- Conditions
- Auricular Stimulation
- Keywords
- Healthy Volunteer Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore whether stimulating different outer parts of the ear using a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) will create different brain activation images. Investigators will recruit 24 healthy participants. The ear stimulation will be delivered while taking brain images using a magnetic resonance imaging (MRI) machine.
Detailed description
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that delivers electric stimulation to the auricular branch of the vagus nerve (ABVN). This technique has been demonstrated effective in the treatment of depression and addiction in previous studies.
Most previous applications of taVNS targeted the ABVN via the cymba conchae or tragus sites. The mastoid process (mastoid site) is an important dermatome innervated by the ABVN, but there is currently a lack of knowledge on how taVNS on the mastoid site affects brain activity and whether it differs from the effect of stimulating the cymba site.
In this proposed study, the investigators plan to explore whether delivering taVNS to the mastoid site and the cymba site can induce different patterns of brain activity. Ultimately, if successful, this project will not only deepen our knowledge in basic neuroscience but also have great value in clinical applications since the mastoid site is a much more accessible ABVN target compared to other sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auricular Neurostimulation (Active 1) | Active comparator | Device: Transcutaneous Auricular Neurostimulation (tAN)•Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target -Cymba stimulation (15Hz stimulation of cymba conchae) |
| Auricular Neurostimulation (Active 2) | Active comparator | Device: Transcutaneous Auricular Neurostimulation (tAN)•Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target -Mastoid stimulation (15Hz stimulation of mastoid process) |
| Auricular Neurostimulation (Sham 1) | Sham comparator | Device: Transcutaneous Auricular Neurostimulation (tAN)•Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target -Sham (15Hz stimulation of the earlobe) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65
- Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
Key exclusion criteria (13 listed)
- Unable to speak in English.
- Contraindicated for MRI.
- Any current or recent untreated medical, neurological, or psychiatric conditions
- Metal implant devices in the head, heart or neck.
- History of brain surgery.
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 Neurostimulation (tAN)The intervention the investigators are studying is called transcutaneous auricular neurostimulation (tAN). tAN is simply electrical nerve stimulation administered at the ear which targets the auricular branch of the vagus nerve (ABVN) at the cymba conchae and mastoid process, and to a sham site (earlobe). | Device | Auricular Neurostimulation (Active 1), Auricular Neurostimulation (Active 2), Auricular Neurostimulation (Sham 1) |
Primary outcome
Blood oxygen level-dependent (BOLD) signal changes during stimulation relative to sham stimulation
Time frame: 30 minutes
taVNS will be administered to participants within the bore of the MRI scanner while the investigators acquire high-resolution functional neuroimaging. Both a general linear model and SNM approach will be used to examine BOLD signal changes during stimulation relative to rest blocks, comparing each of the 3 stimulation targets within- and between- subjects to identify any differences in brain activity during stimulation of the mastoid site compared to the cymba site and sham site.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Auricular Stimulation
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder
Insomnia
Active, not recruiting
Auricular VNS Following Subarachnoid Hemorrhage
Subarachnoid Hemorrhage
Not yet recruiting
Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Cognition, Dual-Task Performance, and Interoceptive Accuracy
Cognition, Healthy Volunteers
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
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.
Xiaolong Peng principal investigator
Medical University of South Carolina
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 Neurostimulation (tAN) in people with Auricular 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 2 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 4 Jul 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood oxygen level-dependent (BOLD) signal changes during stimulation relative to sham stimulation (time frame: 30 minutes). 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 4 Jul 2025.