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| Name | Class |
|---|---|
| Georgia Institute of Technology | OTHER |
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The tasks of the project are to map the potency and kinetics of the neurologic, autonomic peripheral, inflammatory, and behavioral responses to vagal nerve stimulation (VNS) vs. sham treatment, at baseline and in response to stressful traumatic scripts related to personal traumatic events, as well as a series of other stressors.
The purpose of this project is to develop the fundamental physiological understanding of feedback controlled vagal nerve stimulation (VNS) using positron emission tomography (PET) brain imaging and blood biomarker measurement with stress in healthy individuals and individuals with PTSD. Healthy human subjects with a history of psychological trauma but without the diagnosis of a psychiatric disorder (Phase 1), and human subjects with a history of PTSD (Phase 2), undergo PET imaging of the brain in conjunction with VNS or a sham treatment during exposure to neutral scripts and scripts of personal traumatic events. Blood is drawn simultaneously for measurement of a variety of stress responsive biomarkers, including inflammatory markers and neurohormones. A second PET scan with biomarkers assesses the delayed effects of VNS. On two other days subjects undergo exposure to random stressors with VNS or sham in conjunction with measurement of stress biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vagal Nerve Stimulation | Experimental | Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure. |
|
| Sham Stimulation | Sham Comparator | Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GammaCore/electroCore non-invasive VNS device | Device | Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus (the current amplitude) is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V), the burst frequency to 5 kilohertz (kHz), and the envelope frequency to 25 Hz. These are the standard frequency settings that electroCore has demonstrated to be most effective in capturing the vagus nerve based on evoked potential studies. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Interleukin-6 (IL6) | IL6 level will be collected via blood draw. Change is defined as the difference in IL6 level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Tryptophan | Tryptophan level will be collected via blood draw. Change is defined as the difference in tryptophan level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Kynurenine |
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Inclusion Criteria:
Phase 1:
Phase 2:
- Meet criteria for PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID) interview for PTSD.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James D Bremner, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34292205 | Derived | Wittbrodt MT, Gurel NZ, Nye JA, Shandhi MMH, Gazi AH, Shah AJ, Pearce BD, Murrah N, Ko YA, Shallenberger LH, Vaccarino V, Inan OT, Bremner JD. Noninvasive Cervical Vagal Nerve Stimulation Alters Brain Activity During Traumatic Stress in Individuals With Posttraumatic Stress Disorder. Psychosom Med. 2021 Nov-Dec 01;83(9):969-977. doi: 10.1097/PSY.0000000000000987. | |
| 33344717 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Level of Interleukin-6 (IL6) | IL6 level will be collected via blood draw. Change is defined as the difference in IL6 level from baseline to post emotional stress testing. | 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. | Posted | Mean | Standard Deviation | pg/ml | Baseline, Post Stress Testing (Up to 4 Hours) |
|
From the time consent was given through all follow up (up to 4 hours post intervention).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Douglas Bremner | Emory University | 404-712-9569 | doug.bremner@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2019 | Apr 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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|
| Sham gammaCore/electroCore | Device | 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 | Drug | 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. |
|
Kynurenine level will be collected via blood draw. Change is defined as the difference in kynurenine level from baseline to post emotional stress testing.
| Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Kynurenic Acid | 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. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of 3-3 Hydroxykynurenine | 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. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Anthranilic Acid | 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. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Tumor Necrosis Factor (TNF)-Alpha | 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. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Interferon-Gamma | 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. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Interleukin-1 Beta | 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. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Interleukin-2 (IL2) | IL2 level will be collected via blood draw. Change is defined as the difference in IL2 level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Interleukin-4 (IL4) | IL4 level will be collected via blood draw. Change is defined as the difference in IL4 level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Interleukin-8 (IL8) | IL8 level will be collected via blood draw. Change is defined as the difference in IL8 level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Interleukin-10 (IL10) | IL10 level will be collected via blood draw. Change is defined as the difference in IL10 level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Interleukin-12p70 (IL12p70) | IL12p70 level will be collected via blood draw. Change is defined as the difference in IL12p70 level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Interleukin-12p (IL12p) | IL12p level will be collected via blood draw. Change is defined as the difference in IL12p level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Interleukin-13 (IL13) | IL13 level will be collected via blood draw. Change is defined as the difference in IL13 level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Macrophage Migration Inhibitory Factor | 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. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of High-Mobility Group Protein B1 | 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. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Adrenocorticotropic Hormone | 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. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Cortisol | Cortisol level will be collected via blood draw. Change is defined as the difference in cortisol level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Epinephrine | Epinephrine level will be collected via blood draw. Change is defined as the difference in epinephrine level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Dopamine | Dopamine level will be collected via blood draw. Change is defined as the difference in dopamine level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Level of Norepinephrine | Norepinephrine level will be collected via blood draw. Change is defined as the difference in norepinephrine level from baseline to post emotional stress testing. | Baseline, Post Stress Testing (Up to 4 Hours) |
| Gurel NZ, Wittbrodt MT, Jung H, Shandhi MMH, Driggers EG, Ladd SL, Huang M, Ko YA, Shallenberger L, Beckwith J, Nye JA, Pearce BD, Vaccarino V, Shah AJ, Inan OT, Bremner JD. Transcutaneous cervical vagal nerve stimulation reduces sympathetic responses to stress in posttraumatic stress disorder: A double-blind, randomized, sham controlled trial. Neurobiol Stress. 2020 Oct 20;13:100264. doi: 10.1016/j.ynstr.2020.100264. eCollection 2020 Nov. |
| 32960179 | Derived | Gazi AH, Gurel NZ, Richardson KLS, Wittbrodt MT, Shah AJ, Vaccarino V, Bremner JD, Inan OT. Digital Cardiovascular Biomarker Responses to Transcutaneous Cervical Vagus Nerve Stimulation: State-Space Modeling, Prediction, and Simulation. JMIR Mhealth Uhealth. 2020 Sep 22;8(9):e20488. doi: 10.2196/20488. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Level of Tryptophan | Tryptophan level will be collected via blood draw. Change is defined as the difference in tryptophan level from baseline to post emotional stress testing. | 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. | Posted | Mean | Standard Deviation | micromole/l | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of Kynurenine | Kynurenine level will be collected via blood draw. Change is defined as the difference in kynurenine level from baseline to post emotional stress testing. | 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. | Posted | Mean | Standard Deviation | µM | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of Kynurenic Acid | 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. | 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. | Posted | Mean | Standard Deviation | pmol/100 microliters | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of 3-3 Hydroxykynurenine | 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. | This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature. | Posted | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
| Secondary | Level of Anthranilic Acid | 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. | 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. | Posted | Mean | Standard Deviation | nM | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of Tumor Necrosis Factor (TNF)-Alpha | 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. | 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. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of Interferon-Gamma | 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. | 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. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of Interleukin-1 Beta | 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. | 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. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of Interleukin-2 (IL2) | IL2 level will be collected via blood draw. Change is defined as the difference in IL2 level from baseline to post emotional stress testing. | 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. | Posted | Mean | Standard Error | pg/ml | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of Interleukin-4 (IL4) | IL4 level will be collected via blood draw. Change is defined as the difference in IL4 level from baseline to post emotional stress testing. | This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature. | Posted | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
| Secondary | Level of Interleukin-8 (IL8) | IL8 level will be collected via blood draw. Change is defined as the difference in IL8 level from baseline to post emotional stress testing. | This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature. | Posted | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
| Secondary | Level of Interleukin-10 (IL10) | IL10 level will be collected via blood draw. Change is defined as the difference in IL10 level from baseline to post emotional stress testing. | This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature. | Posted | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
| Secondary | Level of Interleukin-12p70 (IL12p70) | IL12p70 level will be collected via blood draw. Change is defined as the difference in IL12p70 level from baseline to post emotional stress testing. | 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. | Posted | Mean | Standard Deviation | pg/ml | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of Interleukin-12p (IL12p) | IL12p level will be collected via blood draw. Change is defined as the difference in IL12p level from baseline to post emotional stress testing. | This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature. | Posted | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
| Secondary | Level of Interleukin-13 (IL13) | IL13 level will be collected via blood draw. Change is defined as the difference in IL13 level from baseline to post emotional stress testing. | 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. | Posted | Mean | Standard Deviation | pg/ml | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of Macrophage Migration Inhibitory Factor | 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. | 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. | Posted | Mean | Standard Deviation | pg/ml | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of High-Mobility Group Protein B1 | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
|
| Secondary | Level of Adrenocorticotropic Hormone | 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. | This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature. | Posted | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
| Secondary | Level of Cortisol | Cortisol level will be collected via blood draw. Change is defined as the difference in cortisol level from baseline to post emotional stress testing. | This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature. | Posted | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
| Secondary | Level of Epinephrine | Epinephrine level will be collected via blood draw. Change is defined as the difference in epinephrine level from baseline to post emotional stress testing. | This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature. | Posted | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
| Secondary | Level of Dopamine | Dopamine level will be collected via blood draw. Change is defined as the difference in dopamine level from baseline to post emotional stress testing. | This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature. | Posted | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
| Secondary | Level of Norepinephrine | Norepinephrine level will be collected via blood draw. Change is defined as the difference in norepinephrine level from baseline to post emotional stress testing. | This outcome was not assessed due to a lack of resources and a focus on other pertinent biomarkers per the literature. | Posted | Baseline, Post Stress Testing (Up to 4 Hours) |
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 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. | 0 | 29 | 0 | 29 | 0 | 29 |
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