Trial Outcomes & Findings for Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1 (NCT NCT06381102)
NCT ID: NCT06381102
Last Updated: 2025-08-24
Results Overview
Tolerability will be assessed with a questionnaire with scores ranging from 0 -10 (with 0 being no irritation or discomfort and 10 being the worst possible irritation or discomfort) for irritation from tingling/tickling/pricking during taVNS.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
3 hours
Results posted on
2025-08-24
Participant Flow
Participants will be randomized in Period 1 to receive either taVNS 30/30 first or taVNS 10/10 first then the participants will washout for 5 days and will then switch and crossover in Period 2 to receive the opposite treatment from what they received in Period 1 which will be either the taVNS 30/30 first or the taVNS 10/10 first depending on what they were first originally randomized to in Period 1.
Participant milestones
| Measure |
taVNS 30/30 Group
Participants in the group taVNS 30/30 will be in this group for up to 3 hours.
transcutaneous auricular vagus nerve stimulation 30/30: 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 30 second on and 30 second off, for 1 hour, in-person.
|
taVNS 10/10 Group
Participants in the group taVNS 10/10 will be in this group for up to 3 hours.
transcutaneous auricular vagus nerve stimulation 10/10: 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 10 second on and 10 second off, for 1 hour, in-person.
|
|---|---|---|
|
Intervention 1
STARTED
|
17
|
14
|
|
Intervention 1
COMPLETED
|
17
|
14
|
|
Intervention 1
NOT COMPLETED
|
0
|
0
|
|
Washout 5 Days
STARTED
|
17
|
14
|
|
Washout 5 Days
COMPLETED
|
17
|
12
|
|
Washout 5 Days
NOT COMPLETED
|
0
|
2
|
|
Intervention 2
STARTED
|
17
|
12
|
|
Intervention 2
COMPLETED
|
17
|
12
|
|
Intervention 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
taVNS 30/30 Group
Participants in the group taVNS 30/30 will be in this group for up to 3 hours.
transcutaneous auricular vagus nerve stimulation 30/30: 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 30 second on and 30 second off, for 1 hour, in-person.
|
taVNS 10/10 Group
Participants in the group taVNS 10/10 will be in this group for up to 3 hours.
transcutaneous auricular vagus nerve stimulation 10/10: 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 10 second on and 10 second off, for 1 hour, in-person.
|
|---|---|---|
|
Washout 5 Days
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1
Baseline characteristics by cohort
| Measure |
taVNS 30/30 Group
n=17 Participants
Participants in the group taVNS 30/30 will be in this group for up to 3 hours.
Transcutaneous auricular vagus nerve stimulation 30/30: 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 30 second on and 30 second off, for 1 hour, in-person.
|
taVNS 10/10 Group
n=14 Participants
Participants in the group taVNS 10/10 will be in this group for up to 3 hours.
Transcutaneous auricular vagus nerve stimulation 10/10: 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 10 second on and 10 second off, for 1 hour, in-person.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
29.2 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 hoursTolerability will be assessed with a questionnaire with scores ranging from 0 -10 (with 0 being no irritation or discomfort and 10 being the worst possible irritation or discomfort) for irritation from tingling/tickling/pricking during taVNS.
Outcome measures
| Measure |
taVNS 30/30 Group
n=29 Participants
Participants in the group taVNS 30/30 will be in this group for up to 3 hours.
transcutaneous auricular vagus nerve stimulation 30/30: 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 30 second on and 30 second off, for 1 hour, in-person.
|
taVNS 10/10 Group
n=29 Participants
Participants in the group taVNS 10/10 will be in this group for up to 3 hours.
transcutaneous auricular vagus nerve stimulation 10/10: 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 10 second on and 10 second off, for 1 hour, in-person.
|
|---|---|---|
|
Tolerability Measured by Tolerability Questionnaire
|
2.2 score on a scale
Standard Deviation 1.8
|
2.2 score on a scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: 3 hoursThe number of participants who reported mild pain with the intervention.
Outcome measures
| Measure |
taVNS 30/30 Group
n=29 Participants
Participants in the group taVNS 30/30 will be in this group for up to 3 hours.
transcutaneous auricular vagus nerve stimulation 30/30: 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 30 second on and 30 second off, for 1 hour, in-person.
|
taVNS 10/10 Group
n=29 Participants
Participants in the group taVNS 10/10 will be in this group for up to 3 hours.
transcutaneous auricular vagus nerve stimulation 10/10: 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 10 second on and 10 second off, for 1 hour, in-person.
|
|---|---|---|
|
Tolerability Measured by Self-report
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 hoursHRV will be measured with an H10 chest strap device. Values after stimulation will be subtracted from baseline values; thus, a positive number will indicate an increase in HRV post taVNS measured in milliseconds.
Outcome measures
| Measure |
taVNS 30/30 Group
n=29 Participants
Participants in the group taVNS 30/30 will be in this group for up to 3 hours.
transcutaneous auricular vagus nerve stimulation 30/30: 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 30 second on and 30 second off, for 1 hour, in-person.
|
taVNS 10/10 Group
n=29 Participants
Participants in the group taVNS 10/10 will be in this group for up to 3 hours.
transcutaneous auricular vagus nerve stimulation 10/10: 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 10 second on and 10 second off, for 1 hour, in-person.
|
|---|---|---|
|
Change in Heart Rate Variability (HRV)
|
7.2 Milliseconds
Standard Deviation 12.2
|
4.4 Milliseconds
Standard Deviation 12.1
|
Adverse Events
taVNS 30/30 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
taVNS 10/10 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marlon Wong, Associate Professor of Clinical
University of Miami
Phone: 3052842670
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place