Trial Outcomes & Findings for Understanding the Effects of Transauricular Vagus Nerve Stimulation on Neural Networks and Autonomic Nervous System (NCT NCT05801809)
NCT ID: NCT05801809
Last Updated: 2025-12-10
Results Overview
Resting-state EEG was recorded using a 64-channel high-density EGI system (Electrical Geodesics, Inc., Eugene, USA) under the eyes closed condition. Data was filtered into standard frequency bands using short-time Fourier transformation (STFT): delta (0.5-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-80 Hz). Frontal asymmetry was computed as the difference in power between homologous left and right frontal electrodes (e.g., F3-F4) in the alpha band.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Change from baseline to 60 minutes post-intervention.
Results posted on
2025-12-10
Participant Flow
Participant milestones
| Measure |
Active taVNS
TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hz, 200-250 us, and with adjustable intensity for 60 min.
Transauricular vagus nerve stimulation (taVNS): 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).
|
Sham taVNS
Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min there will be no current and the device will be turned off.
Transauricular vagus nerve stimulation (taVNS): 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).
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|---|---|---|
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Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Understanding the Effects of Transauricular Vagus Nerve Stimulation on Neural Networks and Autonomic Nervous System
Baseline characteristics by cohort
| Measure |
Active taVNS
n=22 Participants
TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hz, 200-250 us, and with adjustable intensity for 60 min.
Transauricular vagus nerve stimulation (taVNS): 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).
|
Sham taVNS
n=22 Participants
Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min there will be no current and the device will be turned off.
Transauricular vagus nerve stimulation (taVNS): 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).
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Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=4 Participants
|
20 Participants
n=50 Participants
|
37 Participants
n=681 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
7 Participants
n=681 Participants
|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 68.2 • n=4 Participants
|
40.8 years
STANDARD_DEVIATION 17.8 • n=50 Participants
|
41.3 years
STANDARD_DEVIATION 20.2 • n=681 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=4 Participants
|
12 Participants
n=50 Participants
|
27 Participants
n=681 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=4 Participants
|
10 Participants
n=50 Participants
|
17 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=4 Participants
|
5 Participants
n=50 Participants
|
7 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=4 Participants
|
17 Participants
n=50 Participants
|
37 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=4 Participants
|
7 Participants
n=50 Participants
|
10 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=681 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=4 Participants
|
11 Participants
n=50 Participants
|
25 Participants
n=681 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
5 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=681 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=4 Participants
|
22 participants
n=50 Participants
|
44 participants
n=681 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 60 minutes post-intervention.Resting-state EEG was recorded using a 64-channel high-density EGI system (Electrical Geodesics, Inc., Eugene, USA) under the eyes closed condition. Data was filtered into standard frequency bands using short-time Fourier transformation (STFT): delta (0.5-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-80 Hz). Frontal asymmetry was computed as the difference in power between homologous left and right frontal electrodes (e.g., F3-F4) in the alpha band.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hz, 200-250 us, and with adjustable intensity for 60 min.
Transauricular vagus nerve stimulation (taVNS): 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).
|
Sham taVNS
n=22 Participants
Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min there will be no current and the device will be turned off.
Transauricular vagus nerve stimulation (taVNS): 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).
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|---|---|---|
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Resting-state Electroencephalogram (EEG)
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0.016 Difference in alpha asymmetry (µV²).
Standard Deviation 0.012
|
-0.025 Difference in alpha asymmetry (µV²).
Standard Deviation 0.016
|
PRIMARY outcome
Timeframe: Change from baseline to 60 minutes post-taVNS.Pain intensity was measured using the Numeric Pain Scale (NPS; 0 = no pain, 10 = worst pain). Higher scores indicate worse pain. A "pain-6 temperature" was first identified (temperature that elicits NPS = 6). Test stimulus: Pain-6 temperature applied for 30s; participants rated pain at 10, 20, and 30s. The test-stimulus score is the average of the three NPS ratings. Conditioned stimulus: After 5 minutes, the left hand was immersed in 10-12°C water for 30s while the same pain-6 temperature was applied again. Pain was rated the same way, and the conditioned-stimulus score is the average of the three NPS ratings. CPM calculation = (test-stimulus average) - (conditioned-stimulus average). Positive values = better endogenous pain inhibition; negative values = worse.
Outcome measures
| Measure |
Active taVNS
n=22 Participants
TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hz, 200-250 us, and with adjustable intensity for 60 min.
Transauricular vagus nerve stimulation (taVNS): 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).
|
Sham taVNS
n=19 Participants
Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min there will be no current and the device will be turned off.
Transauricular vagus nerve stimulation (taVNS): 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).
|
|---|---|---|
|
Conditioned Pain Modulation (CPM) Response - Change in Pain Ratings on the Pain-6 Scale (0-10)
|
0.34 Unit on a scale (NPS 0-10)
Standard Deviation 0.60
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-0.53 Unit on a scale (NPS 0-10)
Standard Deviation 1.14
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SECONDARY outcome
Timeframe: Post-intervention (after 60 minutes of taVNS)HRV from ECG on non-dominant hand. High-frequency HRV calculated from 5-min resting recordings; higher values indicate greater parasympathetic activity. Post-stimulation values (60 min) were analyzed.
Outcome measures
| Measure |
Active taVNS
n=22 Participants
TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hz, 200-250 us, and with adjustable intensity for 60 min.
Transauricular vagus nerve stimulation (taVNS): 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).
|
Sham taVNS
n=22 Participants
Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min there will be no current and the device will be turned off.
Transauricular vagus nerve stimulation (taVNS): 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).
|
|---|---|---|
|
Heart Rate Variability (HRV)
|
0.6 ms²
Standard Deviation 0.3
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0.1 ms²
Standard Deviation 0.2
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Adverse Events
Active taVNS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham taVNS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active taVNS
n=22 participants at risk
TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hz, 200-250 us, and with adjustable intensity for 60 min.
Transauricular vagus nerve stimulation (taVNS): 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).
|
Sham taVNS
n=22 participants at risk
Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min there will be no current and the device will be turned off.
Transauricular vagus nerve stimulation (taVNS): 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).
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|---|---|---|
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Ear and labyrinth disorders
Expected side effect
|
4.5%
1/22 • Number of events 1 • Side effects were assessed on the same day, immediately after the stimulation.
No serious or unforeseen adverse events were documented. Only one participant in the active group reported transient tingling behind their left ear at the onset of stimulation, dissipating within the subsequent five minutes.
|
0.00%
0/22 • Side effects were assessed on the same day, immediately after the stimulation.
No serious or unforeseen adverse events were documented. Only one participant in the active group reported transient tingling behind their left ear at the onset of stimulation, dissipating within the subsequent five minutes.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place