HealthyNCT06614933
How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?
A study testing Biphasic transcutaneous auricular vagus nerve stimulation and Monophasic transcutaneous auricular vagus nerve stimulation in people with Healthy, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Biphasic transcutaneous auricular vagus nerve stimulation and Monophasic transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2024to 7 Jun 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between the ages of 18-80 years
- English speaking (must be able to consent and complete the interviews in English)
Who cannot join
- chronic pain (average intensity \>2/10 on 0-10 scale, for longer than 3 months)
- acute pain of intensity greater than 3/10
- chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
- any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
- pregnancy
- currently taking Buprenorphine or recently stopped taking (within 1 month)
Show all 11Show fewer
- presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
- implants in the head or neck, cochlear implants, or pacemaker
- head or neck metastasis or recent ear trauma
- history of epilepsy
- history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami, Plumer Building
Coral Gables, Florida, 33146
About this study
The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.
- Conditions
- Healthy
- Being tested
- Biphasic transcutaneous auricular vagus nerve stimulation, Monophasic transcutaneous auricular vagus nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic transcutaneous auricular vagus nerve stimulationDevice
Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a biphasic current, continuous at 25 Hz, for 1 hour, in-person.
Monophasic transcutaneous auricular vagus nerve stimulationDevice
Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a monophasic current, with a 50% duty cycle at 25 Hz, for 1-hour, in-person.
| Study group | Role | What they receive |
|---|---|---|
| Biphasic followed by monophasic taVNS group | Experimental | Participants in the group "Biphasic followed by monophasic taVNS" will be in this group for up to 6 hours. Receives: Device: Biphasic transcutaneous auricular vagus nerve stimulation; Device: Monophasic transcutaneous auricular vagus nerve stimulation |
| Monophasic followed by biphasic taVNS group | Active comparator | Participants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours. Receives: Device: Biphasic transcutaneous auricular vagus nerve stimulation; Device: Monophasic transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability Measured by Tolerability Questionnaire
Tolerability will be assessed with a questionnaire with scores ranging from 0 (no discomfort) to 10 (worst pain imaginable) for comfort.
Measured: Up to 3 hours
Tolerability Measured by Self Report
Tolerability will be assessed by self-report using semi-structured interviews conducted at the end of each study visit. Participants will report whether they experienced mild pain during each transcutaneous auricular vagus nerve stimulation (taVNS) protocol. The outcome measure is the count of participants who reported mild pain, as collected during interviews conducted at the end of each visit.
Measured: Up to 3 hours
Secondary outcomes (1)
Change in Heart Rate Variability (HRV)
Heart rate variability (HRV) will be measured using an H10 chest strap device and expressed in milliseconds. Values after stimulation will be subtracted from baseline values; thus, a positive number will indicate an increase in HRV post taVNS.
Measured: Baseline and up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start15 Dec 2024
- Primary completion7 Jun 2025
- Study completion7 Jun 2025
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlon Wong, University of Miami
- Investigators
- Marlon Wong, PT, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614933
- Sponsor's protocol ID
- 20240796
- Status last verified
- Apr 2026
- First submitted
- 23 Sep 2024
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gonzalez G, O'Malley M, Bolanos J, Taylor D, McTeague LM, Canepa A, Wong ML. Participant-centered tolerability of transcutaneous auricular vagus nerve stimulation: insights from two crossover studies. Bioelectron Med. 2026 May 8;12(1):12. doi: 10.1186/s42234-026-00206-y.
PubMed 42098884
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?
- ClinicalTrials.gov ID
- NCT06614933
- Acronym / sponsor ID
- 20240796
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 7 Jun 2025 (actual)
- Study completion
- 7 Jun 2025 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Posted 28 May 2026
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 research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biphasic followed by monophasic taVNS group | Experimental | Device: Biphasic transcutaneous auricular vagus nerve stimulation, Device: Monophasic transcutaneous auricular vagus nerve stimulationParticipants in the group "Biphasic followed by monophasic taVNS" will be in this group for up to 6 hours. |
| Monophasic followed by biphasic taVNS group | Active comparator | Device: Biphasic transcutaneous auricular vagus nerve stimulation, Device: Monophasic transcutaneous auricular vagus nerve stimulationParticipants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- between the ages of 18-80 years
- English speaking (must be able to consent and complete the interviews in English)
Key exclusion criteria (11 listed)
- chronic pain (average intensity \>2/10 on 0-10 scale, for longer than 3 months)
- acute pain of intensity greater than 3/10
- chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
- any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
- pregnancy
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 |
|---|---|---|
| Biphasic transcutaneous auricular vagus nerve stimulationTransauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a biphasic current, continuous at 25 Hz, for 1 hour, in-person. | Device | Biphasic followed by monophasic taVNS group, Monophasic followed by biphasic taVNS group |
| Monophasic transcutaneous auricular vagus nerve stimulationTransauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a monophasic current, with a 50% duty cycle at 25 Hz, for 1-hour, in-person. | Device | Biphasic followed by monophasic taVNS group, Monophasic followed by biphasic taVNS group |
Primary outcome
Tolerability Measured by Tolerability Questionnaire
Time frame: Up to 3 hours
Tolerability will be assessed with a questionnaire with scores ranging from 0 (no discomfort) to 10 (worst pain imaginable) for comfort.
Tolerability Measured by Self Report
Time frame: Up to 3 hours
Tolerability will be assessed by self-report using semi-structured interviews conducted at the end of each study visit. Participants will report whether they experienced mild pain during each transcutaneous auricular vagus nerve stimulation (taVNS) protocol. The outcome measure is the count of participants who reported mild pain, as collected during interviews conducted at the end of each visit.
1 secondary outcome
Change in Heart Rate Variability (HRV)
Time frame: Baseline and up to 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42098884Gonzalez G, O'Malley M, Bolanos J, Taylor D, McTeague LM, Canepa A, Wong ML. Participant-centered tolerability of transcutaneous auricular vagus nerve stimulation: insights from two crossover studies. Bioelectron Med. 2026 May 8;12(1):12. doi: 10.1186/s42234-026-00206-y.
- 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.
Marlon Wong, PT, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biphasic transcutaneous auricular vagus nerve stimulation and Monophasic transcutaneous auricular vagus nerve stimulation in people with Healthy, run by University of Miami 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 11 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 28 May 2026. 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 28 May 2026). 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?
Tolerability Measured by Tolerability Questionnaire (time frame: Up to 3 hours). 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?
On the ClinicalTrials.gov record for NCT06614933, which also lists 1 linked publication.
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 28 May 2026.