Trial Outcomes & Findings for Learning and Ear Stimulation (NCT NCT04812015)
NCT ID: NCT04812015
Last Updated: 2025-08-13
Results Overview
Measured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 2 intervals during stimulation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Measured at Baseline and last 10 minutes of stimulation, on average 65 minutes
Results posted on
2025-08-13
Participant Flow
Participant milestones
| Measure |
Dose Group 1
transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes: Sham 60 minutes and taVNS active stimulation for 15 minutes
|
Dose Group 2
taVNS 30 minutes: Sham 45 minutes and taVNS active stimulation for 30 minutes
|
Dose Group 3
taVNS 45 minutes: Sham 30 minutes and taVNS active stimulation for 45 minutes
|
Dose Group 4
taVNS 60 minutes: Sham 15 minutes and taVNS active stimulation for 60 minutes
|
Dose Group 5
taVNS 75 minutes: Sham 0 minutes and taVNS active stimulation for 75 minutes
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
5
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose 1- 1 participant declined to report their sex
Baseline characteristics by cohort
| Measure |
Dose Group 1
n=6 Participants
transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes: Sham 60 minutes and taVNS active stimulation for 15 minutes
|
Dose Group 2
n=6 Participants
taVNS 30 minutes: Sham 45 minutes and taVNS active stimulation for 30 minutes
|
Dose Group 3
n=5 Participants
taVNS 45 minutes: Sham 30 minutes and taVNS active stimulation for 45 minutes
|
Dose Group 4
n=6 Participants
taVNS 60 minutes: Sham 15 minutes and taVNS active stimulation for 60 minutes
|
Dose Group 5
n=5 Participants
taVNS 75 minutes: Sham 0 minutes and taVNS active stimulation for 75 minutes
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
28 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=28 Participants
|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 8.4 • n=6 Participants
|
34.5 years
STANDARD_DEVIATION 12.3 • n=6 Participants
|
38.2 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
32.7 years
STANDARD_DEVIATION 15.9 • n=6 Participants
|
26.8 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 12.2 • n=28 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants • Dose 1- 1 participant declined to report their sex
|
4 Participants
n=6 Participants • Dose 1- 1 participant declined to report their sex
|
3 Participants
n=5 Participants • Dose 1- 1 participant declined to report their sex
|
4 Participants
n=6 Participants • Dose 1- 1 participant declined to report their sex
|
3 Participants
n=5 Participants • Dose 1- 1 participant declined to report their sex
|
17 Participants
n=27 Participants • Dose 1- 1 participant declined to report their sex
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants • Dose 1- 1 participant declined to report their sex
|
2 Participants
n=6 Participants • Dose 1- 1 participant declined to report their sex
|
2 Participants
n=5 Participants • Dose 1- 1 participant declined to report their sex
|
2 Participants
n=6 Participants • Dose 1- 1 participant declined to report their sex
|
2 Participants
n=5 Participants • Dose 1- 1 participant declined to report their sex
|
10 Participants
n=27 Participants • Dose 1- 1 participant declined to report their sex
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=28 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
28 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline and last 10 minutes of stimulation, on average 65 minutesMeasured for standard versus deviant tones during the Auditory Oddball Task. Oddball will be administered at 2 intervals during stimulation.
Outcome measures
| Measure |
Dose Group 1
n=6 Participants
transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes: Sham 60 minutes and taVNS active stimulation for 15 minutes
|
Dose Group 2
n=6 Participants
taVNS 30 minutes: Sham 45 minutes and taVNS active stimulation for 30 minutes
|
Dose Group 3
n=5 Participants
taVNS 45 minutes: Sham 30 minutes and taVNS active stimulation for 45 minutes
|
Dose Group 4
n=5 Participants
taVNS 60 minutes: Sham 15 minutes and taVNS active stimulation for 60 minutes
|
Dose Group 5
n=5 Participants
taVNS 75 minutes: Sham 0 minutes and taVNS active stimulation for 75 minutes
|
|---|---|---|---|---|---|
|
Change in P300 Amplitude
|
.88 microvolts
Standard Deviation 2.01
|
.50 microvolts
Standard Deviation 1.4
|
-.15 microvolts
Standard Deviation 1.8
|
-.26 microvolts
Standard Deviation .61
|
.23 microvolts
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Baseline to end of Active StimulationOutcome measures
| Measure |
Dose Group 1
n=6 Participants
transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes: Sham 60 minutes and taVNS active stimulation for 15 minutes
|
Dose Group 2
n=5 Participants
taVNS 30 minutes: Sham 45 minutes and taVNS active stimulation for 30 minutes
|
Dose Group 3
n=4 Participants
taVNS 45 minutes: Sham 30 minutes and taVNS active stimulation for 45 minutes
|
Dose Group 4
n=5 Participants
taVNS 60 minutes: Sham 15 minutes and taVNS active stimulation for 60 minutes
|
Dose Group 5
n=4 Participants
taVNS 75 minutes: Sham 0 minutes and taVNS active stimulation for 75 minutes
|
|---|---|---|---|---|---|
|
Change in Heart Rate Variability
|
2.9 ms
Standard Deviation 1.6
|
1.9 ms
Standard Deviation .7
|
1.5 ms
Standard Deviation 1.1
|
1.3 ms
Standard Deviation .2
|
1.7 ms
Standard Deviation .6
|
Adverse Events
Dose Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Group 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Group 5
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place