PostTraumatic Stress DisorderPhase 3NCT02992899
Closed Loop Vagal Nerve Stimulation for Patients With Posttraumatic Stress Disorder
A Phase 3 study testing GammaCore/electroCore non-invasive VNS device and O-15 water in people with PostTraumatic Stress Disorder, run by Emory University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PostTraumatic Stress Disorder
- What is being tested?
- GammaCore/electroCore non-invasive VNS device and O-15 water
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2017to 21 Sep 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1:
- Do not meet criteria for post traumatic stress disorder (PTSD) or other major mental disorder as determined by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5 SCID) interview for PTSD
- Have a history of psychological trauma as defined by DSM-5.
- Phase 2:
- Meet criteria for PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID) interview for PTSD.
Who cannot join
- Positive pregnancy test
- Meningitis
- Traumatic brain injury
- Neurological disorder or organic mental disorder
- History of loss of consciousness greater than one minute
- Alcohol abuse or substance abuse or dependence based on the SCID within the past 12 months
Show all 13Show fewer
- Positive toxicology screen
- Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia, based on the SCID
- A history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
- Evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (complete blood count (CBC), blood urea nitrogen (BUN), creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and EKG)
- Active implantable device (i.e. pacemaker)
- Carotid atherosclerosis
- Cervical vagotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed Loop Vagal Nerve Stimulation in Patients With Posttraumatic Stress Disorder
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.
Read the detailed description
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.
- Conditions
- PostTraumatic Stress Disorder
- Being tested
- GammaCore/electroCore non-invasive VNS device, Sham gammaCore/electroCore, O-15 water
- Keywords
- stress disorders, post-traumatic, posttraumatic stress disorder, PTSD, vagal nerve
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GammaCore/electroCore non-invasive VNS deviceDevice
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.
Sham gammaCore/electroCoreDevice
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 waterDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Vagal Nerve Stimulation | Experimental | Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure. Receives: Device: GammaCore/electroCore non-invasive VNS device; Drug: O-15 water |
| Sham Stimulation | Sham comparator | Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure. Receives: Device: Sham gammaCore/electroCore; Drug: O-15 water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Post Stress Testing (Up to 4 Hours)
Secondary outcomes (22)
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.
Measured: Baseline, Post Stress Testing (Up to 4 Hours)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Post Stress Testing (Up to 4 Hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start19 Apr 2017
- Primary completion21 Sep 2019
- Study completion21 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PostTraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Institute of Technology
- Responsible party
- Principal investigator, J. Douglas Bremner, MD, Emory University
- Investigators
- James D Bremner, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992899
- Sponsor's protocol ID
- IRB00091171
- Status last verified
- May 2021
- First submitted
- 12 Dec 2016
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34292205Gurel 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.
PubMed 33344717Gazi 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.
PubMed 32960179
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Loop Vagal Nerve Stimulation in Patients With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02992899
- Acronym / sponsor ID
- IRB00091171
- Conditions
- PostTraumatic Stress Disorder
- Keywords
- stress disorders, post-traumatic, posttraumatic stress disorder, PTSD, vagal nerve
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Institute of Technology
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 21 Sep 2019 (actual)
- Study completion
- 21 Sep 2019 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Posted 19 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagal Nerve Stimulation | Experimental | Device: GammaCore/electroCore non-invasive VNS device, Drug: O-15 waterParticipants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure. |
| Sham Stimulation | Sham comparator | Device: Sham gammaCore/electroCore, Drug: O-15 waterParticipants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Do not meet criteria for post traumatic stress disorder (PTSD) or other major mental disorder as determined by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5 SCID) interview for PTSD
- Have a history of psychological trauma as defined by DSM-5.
- Meet criteria for PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID) interview for PTSD.
Key exclusion criteria (13 listed)
- Positive pregnancy test
- Meningitis
- Traumatic brain injury
- Neurological disorder or organic mental disorder
- History of loss of consciousness greater than one minute
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GammaCore/electroCore non-invasive VNS deviceVasal 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. | Device | Vagal Nerve Stimulation |
| Sham gammaCore/electroCoreSham 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. | Device | Sham Stimulation |
| O-15 waterOxygen-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. | Drug | Sham Stimulation, Vagal Nerve Stimulation |
Primary outcome
Level of Interleukin-6 (IL6)
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
IL6 level will be collected via blood draw. Change is defined as the difference in IL6 level from baseline to post emotional stress testing.
22 secondary outcomes
Level of Tryptophan
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Kynurenine
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Kynurenic Acid
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of 3-3 Hydroxykynurenine
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Anthranilic Acid
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Tumor Necrosis Factor (TNF)-Alpha
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Interferon-Gamma
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Interleukin-1 Beta
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Interleukin-2 (IL2)
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Interleukin-4 (IL4)
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Interleukin-8 (IL8)
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Interleukin-10 (IL10)
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Interleukin-12p70 (IL12p70)
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Interleukin-12p (IL12p)
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Interleukin-13 (IL13)
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Macrophage Migration Inhibitory Factor
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of High-Mobility Group Protein B1
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Adrenocorticotropic Hormone
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Cortisol
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Epinephrine
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Dopamine
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Level of Norepinephrine
Time frame: Baseline, Post Stress Testing (Up to 4 Hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34292205Wittbrodt 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.
- Derived from this study: PubMed 33344717Gurel 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.
- Derived from this study: PubMed 32960179Gazi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James D Bremner, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GammaCore/electroCore non-invasive VNS device and O-15 water in people with PostTraumatic Stress Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Interleukin-6 (IL6) (time frame: Baseline, Post Stress Testing (Up to 4 Hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02992899, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021; AzTrials last refreshed its copy on 1 Nov 2026.