Post-traumatic StressPhase 1/2NCT03858985
Vagal Nerve Stimulation to Probe Inflammation and Brain in Post-traumatic Stress
A Phase 1/2 study testing Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator) in people with Post-traumatic Stress, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The proposal aims to determine if non-invasive vagus nerve stimulation(nVNS) will alter: 1) the peripheral inflammatory biomarker profile, 2) the neural correlates of change in pain stimuli and 3) PTSD symptom severity and 4) life quality and function in Veterans with PTSD. Read more about this study
- Who is it for?
- Ages 21 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress
- What is being tested?
- Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 31 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 21 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects between 21 and 65 years, any race or ethnicity.
- For PTSD: Previously deployed, experienced a traumatic event, and meets Clinician-Administered PTSD Scale for DSM-5(CAPS-5) symptom cluster severity criteria for PTSD diagnosis, as well as CAPS total cut-off score > 33. 3. For CC: Previously deployed, experienced a traumatic event, and fails to meet CAPS-5 symptom cluster severity criteria for PTSD diagnosis with CAPS total cut-off score < 20.
- Capable of complying with study schedule, procedures, and speaks English.
- Able to provide voluntary written informed consent prior to initiation of Visit 1; and be able to commit to the return visit at the end of the study.
Who cannot join
- Rule out significant mental illness, e.g. psychosis, bipolar disorder as well as major depression pre-dating PTSD, based on Structured Clinical Interview for DSM-5(SCID) interview.
- At risk for suicide or homicide(based upon Columbia Suicide Risk Severity Scale(C-SSRS) or BDI-2 screen and follow-up clinical interview).
- Any subject who has undergone evidence-based treatment(CPT or PE) within one month prior to study enrollment or plans to undergo CPT or PE during the study.
- History of head trauma involving loss of consciousness>1 minute and post-concussive symptoms(PCS).
- Chronic pain as defined by pain persisting beyond its ecological alerting function, and clinically defined as lasting longer than 3 months, and/or currently under the care of a chronic pain physician.
- Any condition or therapy that, in the opinion of the investigator and research team, may be significantly worsened by the administration of study treatment or is likely to interfere with the successful collection of the measures required.
Show all 12Show fewer
- Clinically significant uncontrolled/unstable medical illness or clinically significant surgery within 1 month of the screening visit.
- Evidence of a maladaptive pattern of alcohol use or abuse(based on AUDIT-C interview) one month prior to the screening visit and or illicit drug use or abuse as measured by urine screen positive for illicit substances at the screening Visit 1 or follow up Visit 2.
- Participation in a pharmaceutical trial or exposure to investigational drugs within 1 month of the screening visit.
- Standard of care medications used to treat PTSD will be continued. Any subject that takes anti-inflammatory medications for chronic medical conditions or takes other medications for chronic pain will be excluded.
- MRI-related exclusion criteria: A cardiac pacemaker; metal fragments in eyes/skin/body(shrapnel), subjects who have ever been metal workers/welders; history of eye surgery/eyes washed out because of metal, aortic/aneurysm clips, prosthesis, bypass surgery/coronary artery clips, hearing aid, heart-valve replacement, subjects with an intrauterine device, a shunt(ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators; vision problems uncorrectable with lenses; claustrophobia; inability to lie still on their backs for approximately 60 minutes; prior neurosurgery; or unwillingness or inability to remove nose, ear, tongue, or face rings. Any implants will be reviewed for safety.
- Vagus nerve stimulation related criteria: history of carotid endarterectomy, severe carotid artery disease[e.g. bruits on physical exam or history of transient ischemic attack(TIA) or stroke], congestive heart failure(CHF), cardiac arrhythmia, known severe coronary artery disease or recent myocardial infarction(within 5 years), or a history or seizure or syncope(within the last 1 year), or prior neck surgery will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
The proposal aims to determine if non-invasive vagus nerve stimulation(nVNS) will alter: 1) the peripheral inflammatory biomarker profile, 2) the neural correlates of change in pain stimuli and 3) PTSD symptom severity and 4) life quality and function in Veterans with PTSD. The planned inflammatory biomarker and neuroimaging results can 1) promote knowledge of inflammatory and neurobiological mechanisms that contribute to pain in PTSD, and 2) advance the ability to provide targeted neuromodulation based interventions that support improved life quality and function for Veterans. These goals are consistent with the VA's mission to sponsor research examining variables related to pathogenesis, diagnosis, and(ultimately) treatment of neuropsychiatric disorders.
Read the detailed description
Rates of posttraumatic stress disorder (PTSD) are high among combat Veterans with estimates of PTSD within Iraq and Afghanistan Veterans at nearly 17% of active duty and over 24% of reserve service members that screen positive for PTSD. Studies from the current and prior wars have demonstrated that mental disorders, in particular PTSD, are associated with higher rates of: 1) physical symptoms, 2) chronic physical illness and 3) overall mortality. Rates of comorbid PTSD and chronic pain are exceedingly high among Veterans with reports of 30%-50% in both Vietnam and OEF/OIF Veterans, that suggest a shared pathophysiology. Excessive release of peripheral pro-inflammatory cytokines has been implicated in the generation of: 1) pathologic chronic pain states and 2) in PTSD. Perception of an aversive stimulus/threat activates peripheral inflammatory cytokine release, while exogenous administration of an inflammatory stimulus (that also cause release of peripheral inflammatory cytokines) increases the limbic (insular cortex and amygdala) response to aversive/threat stimuli as measured by functional Magnetic Resonance Imaging (fMRI). Work by the investigators' group shows that PTSD influences the: 1) nociceptive response, 2) intrathecal cytokine release and 3) peripheral cytokine release in response to a painful stimulus when compared to responses of Veteran combat controls (CC). Vagus nerve stimulation has been shown to decrease: 1) peripheral inflammatory cytokine release, 2) pain, and 3) anxiety.
Recent work by the group has shown that non-invasive vagal nerve stimulation (nVNS; using extradermal stimulation) decreases peripheral inflammation in healthy control subjects and may similarly decrease hyperinflammation observed in PTSD. In pilot work, the investigators have obtained initial fMRI evidence (preliminary data) suggests that in healthy controls, nVNS decreases insular response to painful stimuli, which is known to be dysregulated in PTSD.
The investigators plan to use nVNS as a probe in PTSD and CC to observe the effects of vagal nerve modulation on: 1) CNS neural circuit function during pain and pain anticipation stimuli, and 2) peripheral inflammatory biomarker measures. The long-term goal of this line of research is to use nVNS as a probe to obtain pilot data of: 1) peripheral inflammatory biomarkers and 2) fMRI derived brain imaging response to pain, to advance the understanding of fundamental pathophysiology of co-morbid pain and PTSD and to ultimately provide, targeted neuromodulation based interventions for Veterans with pain and PTSD. The investigators will study two groups [(PTSD, CC), (both without chronic pain diagnosis)], under two conditions (either nVNS or Sham stimulation), over three time points (pre-nVNS/Sham), (7 days post-nVNS/Sham) and one month after treatment (one month post VNS/Sham). The first objective of this proposal, is to measure peripheral inflammation in response to nVNS treatment in order to delineate peripheral inflammation based biomarker profiles of treatment responsiveness to nVNS in PTSD and CC. The second step is to measure brain region response to a pain and pain anticipation stimuli task before and after nVNS treatment in order to demonstrate: 1) a neural profile of treatment responsiveness to nVNS and 2) the neural profile of nVNS effects on pain in PTSD and CC. Participants will receive a 7-day long nVNS/Sham trial where inflammatory biomarkers, neuroimaging tools, PTSD symptom severity and functional life quality will be assessed before and after the 7 days. Additionally, PTSD symptom severity and functional life quality will be assessed one month after study onset. The direct contrast of pre and post nVNS/Sham will provide an objective and sensitive assessment of neuromodulation with nVNS and lay the groundwork for further neuromodulation based study in PTSD. Such outcomes may provide additional evidence of potential treatment efficacy, thus ultimately provide therapies that enhance VA clinical practice guidelines.
- Conditions
- Post-traumatic Stress
- Being tested
- Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator), Cervical Transcutaneous Vagus Nerve Stimulation (Sham Comparator)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator)Device
Both sham and active nVNS treatment produce low-voltage electrical signal that induce reliable sensation on subject skin on upper anterior cervical area (overlying carotid artery).
Cervical Transcutaneous Vagus Nerve Stimulation (Sham Comparator)Device
Both sham and active nVNS treatment produce low-voltage electrical signal that induce reliable sensation on subject skin on upper anterior cervical area (overlying carotid artery).
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation | Active comparator | Cervical Transcutaneous vagus nerve stimulation. Participants will undergo once daily cervical transcutaneous vagus nerve stimulation. Receives: Device: Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator) |
| Sham Vagus Nerve Stimulation | Sham comparator | Sham Cervical Transcutaneous Vagus Nerve Stimulation. Participants will undergo once daily sham cervical transcutaneous vagus nerve stimulation. Receives: Device: Cervical Transcutaneous Vagus Nerve Stimulation (Sham Comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural Effects Measured by Functional MRI
Examining fMRI derived hemodynamic response curve during rest and pain challenge carried out at baseline to week 1 of 1x daily treatment.
Measured: Functional Imaging Brain Response Measured with Functional MRI: [Time Frame: baseline to week 1 of 1x daily treatment)]
Peripheral Blood Inflammatory Cytokine Measurement
Peripheral Blood will be drawn to examine concentrations of plasma cytokines in response to sham or nVNS. Cytokine concentrations are measured with in tube whole blood culture system. Peripheral blood cytokine concentration will be quantified in picogram/milliliter.
Measured: Peripheral Blood Inflammatory Cytokine Measurement: [Time Frame: baseline to week 1 of 1x daily treatment)]
Secondary outcomes (3)
Clinician Administered PTSD Scale
This semi-structured interview is designed to measure posttraumatic stress disorder diagnostic status as well as symptoms severity. Total scores range from 0 to 20 with higher scores indicating greater severity; change over time will be evaluated.
Measured: Clinician Administered PTSD Scale: [Time Frame: baseline to week 1 of 1x daily treatment)]
Sheehan Disability Scale (SDS)
The Sheehan Disability Scale (SDS) was developed to assess functional impairment in three inter-related domains: work/school, social and family life. It utilizes a 10 point visual analog scale that incorporates spatiovisual, numeric and verbal descriptive anchors to simultaneously assess disability.
Measured: Sheehan Disability Scale (SDS): [Time Frame: baseline to week 1 of 1x daily treatment and post treatment week 5)]
WHODAS 2.0
The WHODAS 2.0 was developed to assess functional impairment and possesses strong psychometric properties and provides a global disability score as well as six domain scores: cognition, mobility, self-care, getting along with others, participation in society, and life activities. Scores change over time will be evaluated.
Measured: WHODAS 2.0: [Time Frame: baseline to week 1 of 1x daily treatment and post treatment week 5)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start4 Feb 2019
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic StressStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A sham and active non-invasive vagus nerve stimulator (nVNS) will be used. Both sham and active produce reliable sensation on subject skin over the cervical neck area. The sham device is identical in appearance to the nVNS device. Both devices carry out stimulation for the exact same time period, approximately 2 minutes. Subjects are assigned to sham and nVNS device therapy given once daily for 1 week.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Imanuel R Lerman, MD MSc, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858985
- Sponsor's protocol ID
- D2920-W
- Status last verified
- Apr 2025
- First submitted
- 13 Feb 2019
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagal Nerve Stimulation to Probe Inflammation and Brain in Post-traumatic Stress
- ClinicalTrials.gov ID
- NCT03858985
- Acronym / sponsor ID
- D2920-W
- Conditions
- Post-traumatic Stress
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposal aims to determine if non-invasive vagus nerve stimulation(nVNS) will alter: 1) the peripheral inflammatory biomarker profile, 2) the neural correlates of change in pain stimuli and 3) PTSD symptom severity and 4) life quality and function in Veterans with PTSD. The planned inflammatory biomarker and neuroimaging results can 1) promote knowledge of inflammatory and neurobiological mechanisms that contribute to pain in PTSD, and 2) advance the ability to provide targeted neuromodulation based interventions that support improved life quality and function for Veterans. These goals are consistent with the VA's mission to sponsor research examining variables related to pathogenesis, diagnosis, and(ultimately) treatment of neuropsychiatric disorders.
Detailed description
Rates of posttraumatic stress disorder (PTSD) are high among combat Veterans with estimates of PTSD within Iraq and Afghanistan Veterans at nearly 17% of active duty and over 24% of reserve service members that screen positive for PTSD. Studies from the current and prior wars have demonstrated that mental disorders, in particular PTSD, are associated with higher rates of: 1) physical symptoms, 2) chronic physical illness and 3) overall mortality. Rates of comorbid PTSD and chronic pain are exceedingly high among Veterans with reports of 30%-50% in both Vietnam and OEF/OIF Veterans, that suggest a shared pathophysiology. Excessive release of peripheral pro-inflammatory cytokines has been implicated in the generation of: 1) pathologic chronic pain states and 2) in PTSD. Perception of an aversive stimulus/threat activates peripheral inflammatory cytokine release, while exogenous administration of an inflammatory stimulus (that also cause release of peripheral inflammatory cytokines) increases the limbic (insular cortex and amygdala) response to aversive/threat stimuli as measured by functional Magnetic Resonance Imaging (fMRI). Work by the investigators' group shows that PTSD influences the: 1) nociceptive response, 2) intrathecal cytokine release and 3) peripheral cytokine release in response to a painful stimulus when compared to responses of Veteran combat controls (CC). Vagus nerve stimulation has been shown to decrease: 1) peripheral inflammatory cytokine release, 2) pain, and 3) anxiety.
Recent work by the group has shown that non-invasive vagal nerve stimulation (nVNS; using extradermal stimulation) decreases peripheral inflammation in healthy control subjects and may similarly decrease hyperinflammation observed in PTSD. In pilot work, the investigators have obtained initial fMRI evidence (preliminary data) suggests that in healthy controls, nVNS decreases insular response to painful stimuli, which is known to be dysregulated in PTSD.
The investigators plan to use nVNS as a probe in PTSD and CC to observe the effects of vagal nerve modulation on: 1) CNS neural circuit function during pain and pain anticipation stimuli, and 2) peripheral inflammatory biomarker measures. The long-term goal of this line of research is to use nVNS as a probe to obtain pilot data of: 1) peripheral inflammatory biomarkers and 2) fMRI derived brain imaging response to pain, to advance the understanding of fundamental pathophysiology of co-morbid pain and PTSD and to ultimately provide, targeted neuromodulation based interventions for Veterans with pain and PTSD. The investigators will study two groups [(PTSD, CC), (both without chronic pain diagnosis)], under two conditions (either nVNS or Sham stimulation), over three time points (pre-nVNS/Sham), (7 days post-nVNS/Sham) and one month after treatment (one month post VNS/Sham). The first objective of this proposal, is to measure peripheral inflammation in response to nVNS treatment in order to delineate peripheral inflammation based biomarker profiles of treatment responsiveness to nVNS in PTSD and CC. The second step is to measure brain region response to a pain and pain anticipation stimuli task before and after nVNS treatment in order to demonstrate: 1) a neural profile of treatment responsiveness to nVNS and 2) the neural profile of nVNS effects on pain in PTSD and CC. Participants will receive a 7-day long nVNS/Sham trial where inflammatory biomarkers, neuroimaging tools, PTSD symptom severity and functional life quality will be assessed before and after the 7 days. Additionally, PTSD symptom severity and functional life quality will be assessed one month after study onset. The direct contrast of pre and post nVNS/Sham will provide an objective and sensitive assessment of neuromodulation with nVNS and lay the groundwork for further neuromodulation based study in PTSD. Such outcomes may provide additional evidence of potential treatment efficacy, thus ultimately provide therapies that enhance VA clinical practice guidelines.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A sham and active non-invasive vagus nerve stimulator (nVNS) will be used. Both sham and active produce reliable sensation on subject skin over the cervical neck area. The sham device is identical in appearance to the nVNS device. Both devices carry out stimulation for the exact same time period, approximately 2 minutes. Subjects are assigned to sham and nVNS device therapy given once daily for 1 week.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation | Active comparator | Device: Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator)Cervical Transcutaneous vagus nerve stimulation. Participants will undergo once daily cervical transcutaneous vagus nerve stimulation. |
| Sham Vagus Nerve Stimulation | Sham comparator | Device: Cervical Transcutaneous Vagus Nerve Stimulation (Sham Comparator)Sham Cervical Transcutaneous Vagus Nerve Stimulation. Participants will undergo once daily sham cervical transcutaneous vagus nerve stimulation. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male subjects between 21 and 65 years, any race or ethnicity.
- For PTSD: Previously deployed, experienced a traumatic event, and meets Clinician-Administered PTSD Scale for DSM-5(CAPS-5) symptom cluster severity criteria for PTSD diagnosis, as well as CAPS total cut-off score > 33. 3. For CC: Previously deployed, experienced a traumatic event, and fails to meet CAPS-5 symptom cluster severity criteria for PTSD diagnosis with CAPS total cut-off score < 20.
- Capable of complying with study schedule, procedures, and speaks English.
- Able to provide voluntary written informed consent prior to initiation of Visit 1; and be able to commit to the return visit at the end of the study.
Key exclusion criteria (12 listed)
- Rule out significant mental illness, e.g. psychosis, bipolar disorder as well as major depression pre-dating PTSD, based on Structured Clinical Interview for DSM-5(SCID) interview.
- At risk for suicide or homicide(based upon Columbia Suicide Risk Severity Scale(C-SSRS) or BDI-2 screen and follow-up clinical interview).
- Any subject who has undergone evidence-based treatment(CPT or PE) within one month prior to study enrollment or plans to undergo CPT or PE during the study.
- History of head trauma involving loss of consciousness>1 minute and post-concussive symptoms(PCS).
- Chronic pain as defined by pain persisting beyond its ecological alerting function, and clinically defined as lasting longer than 3 months, and/or currently under the care of a chronic pain physician.
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 |
|---|---|---|
| Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator)Both sham and active nVNS treatment produce low-voltage electrical signal that induce reliable sensation on subject skin on upper anterior cervical area (overlying carotid artery). | Device | Transcutaneous Vagus Nerve Stimulation |
| Cervical Transcutaneous Vagus Nerve Stimulation (Sham Comparator)Both sham and active nVNS treatment produce low-voltage electrical signal that induce reliable sensation on subject skin on upper anterior cervical area (overlying carotid artery). | Device | Sham Vagus Nerve Stimulation |
Primary outcome
Neural Effects Measured by Functional MRI
Time frame: Functional Imaging Brain Response Measured with Functional MRI: [Time Frame: baseline to week 1 of 1x daily treatment)]
Examining fMRI derived hemodynamic response curve during rest and pain challenge carried out at baseline to week 1 of 1x daily treatment.
Peripheral Blood Inflammatory Cytokine Measurement
Time frame: Peripheral Blood Inflammatory Cytokine Measurement: [Time Frame: baseline to week 1 of 1x daily treatment)]
Peripheral Blood will be drawn to examine concentrations of plasma cytokines in response to sham or nVNS. Cytokine concentrations are measured with in tube whole blood culture system. Peripheral blood cytokine concentration will be quantified in picogram/milliliter.
3 secondary outcomes
Clinician Administered PTSD Scale
Time frame: Clinician Administered PTSD Scale: [Time Frame: baseline to week 1 of 1x daily treatment)]
Sheehan Disability Scale (SDS)
Time frame: Sheehan Disability Scale (SDS): [Time Frame: baseline to week 1 of 1x daily treatment and post treatment week 5)]
WHODAS 2.0
Time frame: WHODAS 2.0: [Time Frame: baseline to week 1 of 1x daily treatment and post treatment week 5)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- 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.
Imanuel R Lerman, MD MSc principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator) in people with Post-traumatic Stress, run by VA Office of Research and Development 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 4 inclusion and 12 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 10 Apr 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neural Effects Measured by Functional MRI (time frame: Functional Imaging Brain Response Measured with Functional MRI: [Time Frame: baseline to week 1 of 1x daily treatment)]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2025.