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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biphasic transcutaneous auricular vagus nerve stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and up to 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlon Wong, PT, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami, Plumer Building | Coral Gables | Florida | 33146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42098884 | Derived | 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. |
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All participants will receive both taVNS protocols in random order. Thus, half of the participants will receive Protocol-1 first followed by Protocol-2, and the other half will receive Protocol-2 first followed by Protocol-1.
Only healthy individuals (no patients) will be recruited for this study. All recruitment will be in accordance with the UM Human Subjects and Research Office guidelines. We will only recruit participants via flyers. Participants will be recruited from the University of Miami Department of Physical Therapy, The University of Miami Student Complex, and The University of Miami Health and Wellness Centers, and the community.
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| ID | Title | Description |
|---|---|---|
| FG000 | taVNS Biphasic Waveform Group | Participants in the taVNS biphasic waveform group will be in this group for up to 6 hours. transcutaneous auricular vagus nerve stimulation biphasic waveform: 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 continuous biphasic waveform, for one hour, in person. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1-Protocol 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2024 |
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Participants will be blinded to which protocol they are receiving during data collection. The investigator responsible for processing HRV data will be blinded to group assignment, and investigators will be blinded to group assignment when conducting qualitative data analysis.
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| Monophasic transcutaneous auricular vagus nerve stimulation | Device | 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. |
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| FG001 | taVNS Monophasic Waveform Group | Participants in the taVNS monophasic waveform group will be in this group for up to 6 hours. transcutaneous auricular vagus nerve stimulation monophasic waveform: 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 pulsed 30 seconds on/30 seconds off monophasic waveform, for one hour, in person. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2-Protocol 2 |
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Block randomization with stratification by sex. Per our crossover study design and randomization methods, 16 subjects were randomly assigned to begin with taVNS Biphasic Waveform and 14 subjects were randomly assigned to begin taVNS Monophasic waveform. A total of 30 participants were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | taVNS Biphasic Waveform Group | Participants in the taVNS biphasic waveform group will be in this group for up to 6 hours. transcutaneous auricular vagus nerve stimulation biphasic waveform: 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 continuous biphasic waveform, for one hour, in person. |
| BG001 | taVNS Monophasic Waveform Group | Participants in the taVNS monophasic waveform group will be in this group for up to 6 hours. transcutaneous auricular vagus nerve stimulation monophasic waveform: 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 pulsed 30 seconds on/30 seconds off monophasic waveform, for one hour, in person. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Standard Deviation | score on a scale | Up to 3 hours |
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| Primary | 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. | Posted | Count of Participants | Participants | Up to 3 hours |
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| Secondary | 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. | Posted | Median | Standard Deviation | milliseconds | Baseline and up to 3 hours |
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72 hours
To address the challenge of early identification of an increased risk of a known adverse event, all adverse event data will be tracked and evaluated by the study team on a regular basis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | taVNS Biphasic Waveform Group | Participants in the taVNS biphasic waveform group will be in this group for up to 6 hours. transcutaneous auricular vagus nerve stimulation biphasic waveform: 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 continuous biphasic waveform, for one hour, in person. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG001 | taVNS Monophasic Waveform Group | Participants in the taVNS monophasic waveform group will be in this group for up to 6 hours. transcutaneous auricular vagus nerve stimulation monophasic waveform: 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 pulsed 30 seconds on/30 seconds off monophasic waveform, for one hour, in person. | 0 | 14 | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marlon Wong, PT, PhD | The University of Miami | 3052438117 | Mwong2@med.miami.edu |
| Apr 29, 2026 |
| Prot_SAP_000.pdf |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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Participants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours.
Biphasic transcutaneous auricular vagus nerve stimulation: 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 stimulation: 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.
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