Trial Outcomes & Findings for taVNS Cold Pressor (NCT NCT05254080)
NCT ID: NCT05254080
Last Updated: 2024-01-17
Results Overview
Heart rate will be measured with EKG electrodes before concurrent stress test and ear stimulation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Results posted on
2024-01-17
Participant Flow
Participants were excluded for any major medical comorbidities, as this study only enrolled healthy neurotypical participants. Upon enrollment, participants were automatically randomized to receive active taVNS or sham stimulation first (all participants received both active and sham, the order was randomized).
Participant milestones
| Measure |
Active taVNS Then Sham taVNS
Participants will receive active then sham (placebo) ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
Sham taVNS Then Active taVNS
Participants will receive sham (placebo) then active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
taVNS Cold Pressor
Baseline characteristics by cohort
| Measure |
Active taVNS Then Sham taVNS
n=10 Participants
Participants will receive active then sham (placebo) ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
Sham taVNS Then Active taVNS
n=11 Participants
Participants will receive sham (placebo) then active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.75 years
STANDARD_DEVIATION 5.48 • n=5 Participants
|
29 years
STANDARD_DEVIATION 5.24 • n=7 Participants
|
28.38 years
STANDARD_DEVIATION 5.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 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
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)Heart rate will be measured with EKG electrodes before concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Heart Rate (Before CPT/taVNS)
|
72.86 beats per minute
Standard Deviation 10.88
|
72.0 beats per minute
Standard Deviation 11.77
|
PRIMARY outcome
Timeframe: During concurrent stress test and ear stimulation (average duration of 5 minutes)Heart rate will be measured with EKG electrodes during concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Heart Rate (During CPT/taVNS)
|
83.54 beats per minute
Standard Deviation 16.24
|
83.96 beats per minute
Standard Deviation 16.35
|
PRIMARY outcome
Timeframe: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)Heart rate will be measured with EKG electrodes after concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Heart Rate (After CPT/taVNS)
|
68.97 beats per minute
Standard Deviation 8.65
|
68.78 beats per minute
Standard Deviation 9.54
|
SECONDARY outcome
Timeframe: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) before concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Score of Pain (Before CPT/taVNS)
|
0.05 units on a scale
Standard Deviation 0.22
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: During concurrent stress test and ear stimulation (average duration of 5 minutes)Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) during concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Score of Pain (During CPT/taVNS)
|
5.67 units on a scale
Standard Deviation 2.39
|
5.62 units on a scale
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)Pain will be assessed using a 0-10 scale (where 0 represents no pain at all and 10 represents the worst pain possible) after concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Score of Pain (After CPT/taVNS)
|
0.24 units on a scale
Standard Deviation 0.44
|
0.10 units on a scale
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) before concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Score of Anxiety (Before CPT/taVNS)
|
1.43 units on a scale
Standard Deviation 1.72
|
1.81 units on a scale
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: During concurrent stress test and ear stimulation (average duration of 5 minutes)Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) during concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Score of Anxiety (During CPT/taVNS)
|
3.52 units on a scale
Standard Deviation 2.77
|
3.48 units on a scale
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)Anxiety will be assessed using a 0-10 scale (where 0 represents no anxiety at all and 10 represents the worst anxiety possible) after concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Score of Anxiety (After CPT/taVNS)
|
0.48 units on a scale
Standard Deviation 0.75
|
0.62 units on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) before concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Score of Distress (Before CPT/taVNS)
|
0.29 units on a scale
Standard Deviation 1.10
|
0.33 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: During concurrent stress test and ear stimulation (average duration of 5 minutes)Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) during concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Score of Distress (During CPT/taVNS)
|
4.52 units on a scale
Standard Deviation 3.04
|
4.48 units on a scale
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)Distress will be assessed using a 0-10 scale (where 0 represents no distress at all and 10 represents the worst distress possible) after concurrent stress test and ear stimulation.
Outcome measures
| Measure |
Active taVNS
n=21 Participants
Participants will receive active ear stimulation.
Active taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).
|
Sham taVNS
n=21 Participants
Participants will receive sham (placebo) ear stimulation.
Sham taVNS: Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
|
|---|---|---|
|
Mean Score of Distress (After CPT/taVNS)
|
0.05 units on a scale
Standard Deviation 0.22
|
0.14 units on a scale
Standard Deviation 0.36
|
Adverse Events
Active taVNS
Serious events: 0 serious events
Other events: 0 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
Adverse event data not reported
Additional Information
Dr. Christopher W. Austelle
Medical University of South Carolina
Phone: 843-792-2872
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place