PTSDNCT07523685
Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD)
A study testing non-invasive vagus nerve stimulation in people with PTSD and Post Traumatic Stress Disorder PTSD, run by Acacia Clinics at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the safety and effectiveness of the gammaCore non-invasive vagus nerve stimulation (nVNS) device as an additional treatment for symptoms of post-traumatic stress disorder (PTSD) in adults. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder PTSD, PTSD - Post Traumatic Stress Disorder
- What is being tested?
- non-invasive vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- PTSD diagnosis as determined by the Structured Clinical Interview for DSM-5 (SCID) interview for PTSD
- CAPS-5 score > or = 35
- Between the ages of 18 and 70 years
- Has PTSD symptoms and either is not taking PTSD medications or stable on PTSD medications for 3 months.
- Agrees to refrain from initiating or changing the type, dosage, or frequency of any prophylactic medications for indications other than PTSD that, in the opinion of the clinician may interfere with the study objectives (e.g., antidepressants, anticonvulsants, beta-adrenergic blockers, etc.)
- Agrees to use nVNS as instructed and follow all of the requirements of the study including Follow-up Visit requirements
- Able to provide written informed consent
- Must have a primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial
Who cannot join
- Psychiatric or cognitive disorder and/or behavioral problems that, in the opinion of the clinician, may interfere with the study, such as symptoms of suicidal or homicidal risk.
- Evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (CBC, BUN, creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and EKG), such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness; which in the opinion of the investigator or industry partner interferes with the study
- Cervical vagotomy or structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy)
- Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia)
- Currently implanted with an electrical and/or neurostimulator device (e.g., cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, cochlear implant, sphenopalatine ganglion stimulator, occipital nerve stimulator)
- Pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control
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- Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner)
- Patients with a stellate ganglion block (SGB)
- An employee of the Investigator or the clinical study site
- Recent (within 4 weeks) or concurrent use of a rapid-acting antidepressant agent (e.g., ketamine, esketamine, ECT) and/or other non-invasive stimulation therapy (e.g., TMS, transcranial focused ultrasound)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Acacia Research Center
Sunnyvale, California, 94087
Acacia Research Team, 650-993-9397, research@acaciaclinics.com
Danielle DeSouza, PhD
About this study
Official title: Non-invasive Vagus Nerve Stimulation (nVNS) for Adjunctive Treatment of Symptoms Associated With Post-Traumatic Stress Disorder (PTSD)
The goal of this clinical trial is to evaluate the safety and effectiveness of the gammaCore non-invasive vagus nerve stimulation (nVNS) device as an additional treatment for symptoms of post-traumatic stress disorder (PTSD) in adults.
The vagus nerve connects the brain with many organs and systems in the body and plays a role in regulating stress and emotional responses. The gammaCore device is a handheld, rechargeable medical device that delivers gentle electrical stimulation to the vagus nerve through the skin on the side of the neck. By stimulating this nerve, the device may help reduce PTSD symptoms.
Read more
gammaCore is cleared by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of migraine and cluster headache. It has not yet been approved for the treatment of PTSD. This study is being conducted to better understand whether this type of stimulation may help improve PTSD symptoms and to evaluate its safety when used for this purpose.
The main questions this study aims to answer are:
- Is non-invasive vagus nerve stimulation safe for people with PTSD when used regularly at home?
- Does treatment with the gammaCore device improve PTSD symptom severity over time?
In this study, approximately 40 adults with PTSD will participate in an open-label pilot study.
Participants will first complete a 4-week baseline period in which their PTSD symptoms are monitored. This allows researchers to understand each participant's symptoms before starting the intervention.
Participants will then begin a 12-week treatment period using the gammaCore device at home. During this time, participants will apply the device to the side of the neck for short stimulation sessions each day as instructed by the study team.
Participants will attend six study visits, some conducted remotely and some in person. These visits include screening, training on how to use the device, and follow-up assessments. During the study, participants will complete questionnaires and clinician-administered assessments that measure PTSD symptoms and quality of life. Researchers will also monitor participants for any side effects or medical problems related to the device.
By collecting information on symptoms, safety, and device use, this study will help researchers understand whether non-invasive vagus nerve stimulation could become a useful treatment option for people living with PTSD.
- Conditions
- PTSD, Post Traumatic Stress Disorder PTSD, PTSD - Post Traumatic Stress Disorder, Post Traumatic Stress Disorder, Post Traumatic Stress Disorders, Post-traumatic Stress Disorder (PTSD)
- Being tested
- non-invasive vagus nerve stimulation
- Keywords
- PTSD, nVNS, Non-invasive, vagus nerve stimulation, vagus nerve stimulator, Post-traumatic stress disorder, neuromodulation, non-invasive vagus nerve stimulation (nVNS), Adjunctive treatment of post traumatic stress disorder, gammaCore, VNS, peripheral nerve stimulation, brain stimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive vagus nerve stimulationDevice
Also called Gammacore, Vagus nerve stimulation
The gammaCore device (electroCore, Inc. Rockaway, NJ) is a hand-held device that is applied directly to the neck just medial to the sternocleidomastoid muscle, where the vagus nerve travels along through the carotid sheath on its way to the brain. gammaCore has been cleared for use in patients with intractable cluster headache, episodic migraine, chronic migraine, paroxysmal hemicrania and hemicrania continua.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Vagus Nerve Stimulation Arm | Experimental | Participants will receive treatment with the gammaCore non-invasive vagus nerve stimulation (nVNS) device for symptoms associated with PTSD. After a 4-week baseline period without treatment, participants will begin a 12-week at-home treatment period during which they will self-administer nVNS to the side of the neck using the handheld gammaCore device twice per day, as instructed. Each stimulation lasts approximately 2 minutes. Participants will complete study visits and symptom assessments throughout the study, and safety will be monitored by recording adverse events. Receives: Device: non-invasive vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events (SAEs)
The primary safety measure for this study is the incidence and occurrence of Serious Adverse Events (SAEs) related to non-invasive vagus nerve stimulation (nVNS) treatment using the gammaCore device.
Measured: During the 12-week treatment period
Clinician Administered PTSD Scale (CAPS-5)
The primary efficacy outcome is the change in total Clinician-Administered PTSD Scale (CAPS-5) score (a semi-structured clinical interview).
Measured: From baseline to 12 weeks post-treatment
Secondary outcomes (2)
Post-Traumatic Stress Disorder Checklist for DSM-5
The post-traumatic stress disorder (PTSD) Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire that measures symptoms of PTSD over the past month. Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Measured: From screening to the end of treatment at 12 weeks
Clinician Global Impressions- Improvement Scale
The Clinician Global Impressions- Improvement (CGI-I) scale is a clinician-rated, single-item measure that assesses change in a patient's clinical status relative to baseline. Scores range from 1 ("Very much improved") to 7 ("Very much worse"), with lower scores indicating greater improvement.
Measured: From screening to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start2 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acacia Clinics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ElectroCore INC, Vagus Nerve Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523685
- Sponsor's protocol ID
- PTSD-US-01
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Vagus Nerve Stimulation (nVNS) for Adjunctive Treatment of Symptoms Associated With Post-Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT07523685
- Acronym / sponsor ID
- PTSD-US-01
- Conditions
- PTSD, Post Traumatic Stress Disorder PTSD, PTSD - Post Traumatic Stress Disorder, Post Traumatic Stress Disorder, Post Traumatic Stress Disorders, Post-traumatic Stress Disorder (PTSD)
- Keywords
- PTSD, nVNS, Non-invasive, vagus nerve stimulation, vagus nerve stimulator, Post-traumatic stress disorder, neuromodulation, non-invasive vagus nerve stimulation (nVNS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Acacia ClinicsIndustry (pharma, biotech, devices)
- Collaborators
- ElectroCore INC, Vagus Nerve Society
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Apr 2026 (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 goal of this clinical trial is to evaluate the safety and effectiveness of the gammaCore non-invasive vagus nerve stimulation (nVNS) device as an additional treatment for symptoms of post-traumatic stress disorder (PTSD) in adults.
The vagus nerve connects the brain with many organs and systems in the body and plays a role in regulating stress and emotional responses. The gammaCore device is a handheld, rechargeable medical device that delivers gentle electrical stimulation to the vagus nerve through the skin on the side of the neck. By stimulating this nerve, the device may help reduce PTSD symptoms.
gammaCore is cleared by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of migraine and cluster headache. It has not yet been approved for the treatment of PTSD. This study is being conducted to better understand whether this type of stimulation may help improve PTSD symptoms and to evaluate its safety when used for this purpose.
The main questions this study aims to answer are:
- Is non-invasive vagus nerve stimulation safe for people with PTSD when used regularly at home?
- Does treatment with the gammaCore device improve PTSD symptom severity over time?
In this study, approximately 40 adults with PTSD will participate in an open-label pilot study.
Participants will first complete a 4-week baseline period in which their PTSD symptoms are monitored. This allows researchers to understand each participant's symptoms before starting the intervention.
Participants will then begin a 12-week treatment period using the gammaCore device at home. During this time, participants will apply the device to the side of the neck for short stimulation sessions each day as instructed by the study team.
Participants will attend six study visits, some conducted remotely and some in person. These visits include screening, training on how to use the device, and follow-up assessments. During the study, participants will complete questionnaires and clinician-administered assessments that measure PTSD symptoms and quality of life. Researchers will also monitor participants for any side effects or medical problems related to the device.
By collecting information on symptoms, safety, and device use, this study will help researchers understand whether non-invasive vagus nerve stimulation could become a useful treatment option for people living with PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Vagus Nerve Stimulation Arm | Experimental | Device: non-invasive vagus nerve stimulationParticipants will receive treatment with the gammaCore non-invasive vagus nerve stimulation (nVNS) device for symptoms associated with PTSD. After a 4-week baseline period without treatment, participants will begin a 12-week at-home treatment period during which they will self-administer nVNS to the side of the neck using the handheld gammaCore device twice per day, as instructed. Each stimulation lasts approximately 2 minutes. Participants will complete study visits and symptom assessments throughout the study, and safety will be monitored by recording adverse events. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- PTSD diagnosis as determined by the Structured Clinical Interview for DSM-5 (SCID) interview for PTSD
- CAPS-5 score > or = 35
- Between the ages of 18 and 70 years
- Has PTSD symptoms and either is not taking PTSD medications or stable on PTSD medications for 3 months.
- Agrees to refrain from initiating or changing the type, dosage, or frequency of any prophylactic medications for indications other than PTSD that, in the opinion of the clinician may interfere with the study objectives (e.g., antidepressants, anticonvulsants, beta-adrenergic blockers, etc.)
Key exclusion criteria (10 listed)
- Psychiatric or cognitive disorder and/or behavioral problems that, in the opinion of the clinician, may interfere with the study, such as symptoms of suicidal or homicidal risk.
- Evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (CBC, BUN, creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and EKG), such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness; which in the opinion of the investigator or industry partner interferes with the study
- Cervical vagotomy or structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy)
- Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia)
- Currently implanted with an electrical and/or neurostimulator device (e.g., cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, cochlear implant, sphenopalatine ganglion stimulator, occipital nerve stimulator)
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 |
|---|---|---|
| non-invasive vagus nerve stimulationAlso: Gammacore, Vagus nerve stimulationThe gammaCore device (electroCore, Inc. Rockaway, NJ) is a hand-held device that is applied directly to the neck just medial to the sternocleidomastoid muscle, where the vagus nerve travels along through the carotid sheath on its way to the brain. gammaCore has been cleared for use in patients with intractable cluster headache, episodic migraine, chronic migraine, paroxysmal hemicrania and hemicrania continua. | Device | Non-invasive Vagus Nerve Stimulation Arm |
Primary outcome
Serious Adverse Events (SAEs)
Time frame: During the 12-week treatment period
The primary safety measure for this study is the incidence and occurrence of Serious Adverse Events (SAEs) related to non-invasive vagus nerve stimulation (nVNS) treatment using the gammaCore device.
Clinician Administered PTSD Scale (CAPS-5)
Time frame: From baseline to 12 weeks post-treatment
The primary efficacy outcome is the change in total Clinician-Administered PTSD Scale (CAPS-5) score (a semi-structured clinical interview).
2 secondary outcomes
Post-Traumatic Stress Disorder Checklist for DSM-5
Time frame: From screening to the end of treatment at 12 weeks
Clinician Global Impressions- Improvement Scale
Time frame: From screening to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive vagus nerve stimulation in people with PTSD and Post Traumatic Stress Disorder PTSD, run by Acacia Clinics 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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (SAEs) (time frame: During the 12-week treatment period). 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 8 Oct 2026.