Trial Outcomes & Findings for Closed Loop Vagal Nerve Stimulation for Patients With Posttraumatic Stress Disorder (NCT NCT02992899)
NCT ID: NCT02992899
Last Updated: 2021-06-14
Results Overview
IL6 level will be collected via blood draw. Change is defined as the difference in IL6 level from baseline to post emotional stress testing.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
56 participants
Primary outcome timeframe
Baseline, Post Stress Testing (Up to 4 Hours)
Results posted on
2021-06-14
Participant Flow
Participant milestones
| Measure |
Vagal Nerve Stimulation
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
29
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Vagal Nerve Stimulation
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Closed Loop Vagal Nerve Stimulation for Patients With Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Vagal Nerve Stimulation
n=27 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=29 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 11 • n=5 Participants
|
35 years
STANDARD_DEVIATION 11 • n=7 Participants
|
33 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 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
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 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
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
29 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
IL6 level will be collected via blood draw. Change is defined as the difference in IL6 level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=23 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=22 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Interleukin-6 (IL6)
Baseline IL-6 Level
|
0.88 pg/ml
Standard Deviation 0.59
|
0.84 pg/ml
Standard Deviation 0.61
|
|
Level of Interleukin-6 (IL6)
Post Stress Testing IL-6 Level
|
1.77 pg/ml
Standard Deviation 1.43
|
2.11 pg/ml
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
Tryptophan level will be collected via blood draw. Change is defined as the difference in tryptophan level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=16 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=17 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Tryptophan
Baseline Tryptophan Level
|
50.59 micromole/l
Standard Deviation 11.65
|
55.80 micromole/l
Standard Deviation 15.74
|
|
Level of Tryptophan
Post Stress Testing Tryptophan Level
|
54.42 micromole/l
Standard Deviation 13.21
|
57.79 micromole/l
Standard Deviation 14.38
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
Kynurenine level will be collected via blood draw. Change is defined as the difference in kynurenine level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=16 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=18 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Kynurenine
Baseline Kynurenine Level
|
4.72 µM
Standard Deviation 5.37
|
7.19 µM
Standard Deviation 5.01
|
|
Level of Kynurenine
Post Stress Testing Kynurenine Level
|
5.04 µM
Standard Deviation 5.81
|
7.06 µM
Standard Deviation 5.64
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
Kynurenic acid level will be collected via blood draw. Change is defined as the difference in kynurenic acid level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=7 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=11 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Kynurenic Acid
Baseline Kynurenic Acid Level
|
35.71 pmol/100 microliters
Standard Deviation 9.59
|
43.07 pmol/100 microliters
Standard Deviation 21.13
|
|
Level of Kynurenic Acid
Post Stress Testing Kynurenic Acid Level
|
38.81 pmol/100 microliters
Standard Deviation 16.50
|
37.88 pmol/100 microliters
Standard Deviation 12.37
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature.
3-3 hydroxykynurenine level will be collected via blood draw. Change is defined as the difference in 3-3 hydroxykynurenine level from baseline to post emotional stress testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
Anthranilic Acid level will be collected via blood draw. Change is defined as the difference in anthranilic acid level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=16 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=17 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Anthranilic Acid
Baseline Anthranilic Acid Level
|
8.32 nM
Standard Deviation 2.68
|
7.02 nM
Standard Deviation 1.68
|
|
Level of Anthranilic Acid
Post Stress Testing Anthranilic Acid Level
|
7.49 nM
Standard Deviation 2.13
|
6.90 nM
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
TNF-alpha level will be collected via blood draw. Change is defined as the difference in TNF-alpha level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=16 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=14 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Tumor Necrosis Factor (TNF)-Alpha
Post Stress Testing Tumor Necrosis Factor (TNF)-alpha Level
|
2.63 pg/mL
Standard Deviation 1.03
|
2.26 pg/mL
Standard Deviation 0.74
|
|
Level of Tumor Necrosis Factor (TNF)-Alpha
Baseline Tumor Necrosis Factor (TNF)-alpha Level
|
2.81 pg/mL
Standard Deviation 1.28
|
2.37 pg/mL
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
Interferon-Gamma level will be collected via blood draw. Change is defined as the difference in Interferon-Gamma level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=23 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=22 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Interferon-Gamma
Baseline Interferon-Gamma Level
|
4.75 pg/mL
Standard Deviation 9.61
|
3.43 pg/mL
Standard Deviation 2.58
|
|
Level of Interferon-Gamma
Post Stress Testing Interferon-Gamma Level
|
4.86 pg/mL
Standard Deviation 10.20
|
8.87 pg/mL
Standard Deviation 27.33
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
Interleukin-1 Beta level will be collected via blood draw. Change is defined as the difference in Interleukin-1 Beta level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=16 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=14 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Interleukin-1 Beta
Baseline Interleukin-1 Beta Level
|
0.056 pg/mL
Standard Deviation 0.033
|
0.086 pg/mL
Standard Deviation 0.056
|
|
Level of Interleukin-1 Beta
Post Stress Testing Interleukin-1 Beta Level
|
0.071 pg/mL
Standard Deviation 0.041
|
0.085 pg/mL
Standard Deviation 0.077
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
IL2 level will be collected via blood draw. Change is defined as the difference in IL2 level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=16 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=14 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Interleukin-2 (IL2)
Baseline Interleukin-2 (IL2) Level
|
0.29 pg/ml
Standard Error 0.22
|
0.29 pg/ml
Standard Error 0.20
|
|
Level of Interleukin-2 (IL2)
Post Stress Testing Interleukin-2 (IL2) Level
|
0.36 pg/ml
Standard Error 0.20
|
0.27 pg/ml
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature.
IL4 level will be collected via blood draw. Change is defined as the difference in IL4 level from baseline to post emotional stress testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature.
IL8 level will be collected via blood draw. Change is defined as the difference in IL8 level from baseline to post emotional stress testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature.
IL10 level will be collected via blood draw. Change is defined as the difference in IL10 level from baseline to post emotional stress testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
IL12p70 level will be collected via blood draw. Change is defined as the difference in IL12p70 level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=21 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=20 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Interleukin-12p70 (IL12p70)
Baseline Interleukin-12p70 (IL12p70) Level Level
|
2.20 pg/ml
Standard Deviation 1.48
|
3.22 pg/ml
Standard Deviation 1.68
|
|
Level of Interleukin-12p70 (IL12p70)
Post Stress Testing Interleukin-12p70 (IL12p70) Level Level
|
1.82 pg/ml
Standard Deviation 0.99
|
2.96 pg/ml
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature.
IL12p level will be collected via blood draw. Change is defined as the difference in IL12p level from baseline to post emotional stress testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
IL13 level will be collected via blood draw. Change is defined as the difference in IL13 level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=21 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=20 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Interleukin-13 (IL13)
Baseline Interleukin-13 (IL13) Level
|
33.77 pg/ml
Standard Deviation 16.87
|
43.10 pg/ml
Standard Deviation 18.78
|
|
Level of Interleukin-13 (IL13)
Post Stress Testing Interleukin-13 (IL13) Level
|
29.17 pg/ml
Standard Deviation 14.03
|
43.55 pg/ml
Standard Deviation 31.91
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
Macrophage migration inhibitory factor will be collected via blood draw. Change is defined as the difference in factor level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=21 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=20 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of Macrophage Migration Inhibitory Factor
Baseline Macrophage Migration Inhibitory Factor Level
|
32,204 pg/ml
Standard Deviation 14,130
|
31,309 pg/ml
Standard Deviation 20,624
|
|
Level of Macrophage Migration Inhibitory Factor
Post Stress Testing Macrophage Migration Inhibitory Factor Level
|
30,403 pg/ml
Standard Deviation 14,007
|
30,515 pg/ml
Standard Deviation 17,399
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: Due to technical reasons and/or limited blood draw, the number of participants analyzed is less than the number of participants that completed the trial.
High-mobility group protein B1 level will be collected via blood draw. Change is defined as the difference in high-mobility group protein B1 level from baseline to post emotional stress testing.
Outcome measures
| Measure |
Vagal Nerve Stimulation
n=22 Participants
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
GammaCore/electroCore non-invasive VNS device: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V). The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
Sham Stimulation
n=21 Participants
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
Sham gammaCore/electroCore: Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
O-15 water: Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2\[15O\] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2\[15O\]. Subjects will receive a 20 mCi intravenous bolus of H2\[15O\] for each of the 14 scans during exposure to neutral and traumatic scripts.
|
|---|---|---|
|
Level of High-Mobility Group Protein B1
Baseline High-Mobility Group Protein B1 Level
|
1,552 ng/mL
Standard Deviation 1,105
|
1,734 ng/mL
Standard Deviation 893
|
|
Level of High-Mobility Group Protein B1
Post Stress Testing High-Mobility Group Protein B1 Level
|
1,299 ng/mL
Standard Deviation 574
|
1,691 ng/mL
Standard Deviation 942
|
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature.
Adrenocorticotropic hormone level will be collected via blood draw. Change is defined as the difference in adrenocorticotropic hormone level from baseline to post emotional stress testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature.
Cortisol level will be collected via blood draw. Change is defined as the difference in cortisol level from baseline to post emotional stress testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature.
Epinephrine level will be collected via blood draw. Change is defined as the difference in epinephrine level from baseline to post emotional stress testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature.
Dopamine level will be collected via blood draw. Change is defined as the difference in dopamine level from baseline to post emotional stress testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Stress Testing (Up to 4 Hours)Population: This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature.
Norepinephrine level will be collected via blood draw. Change is defined as the difference in norepinephrine level from baseline to post emotional stress testing.
Outcome measures
Outcome data not reported
Adverse Events
Vagal Nerve Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Stimulation
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