An interventional study of non-invasive vagus nerve stimulation in PTSD, Post Traumatic Stress Disorder PTSD and PTSD - Post Traumatic Stress Disorder, sponsored by Acacia Clinics. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Acacia Clinics · Not applicable, Interventional, and Treatment
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:
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 40 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →This is the only study on the registry with Acacia Clinics as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: non-invasive 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.
Also known as: Gammacore, Vagus nerve stimulation
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.
Time frame: 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).
Time frame: From baseline to 12 weeks post-treatment
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.
Time frame: 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.
Time frame: From screening to the end of treatment at 12 weeks
Patient-Reported Outcomes Measurement Information System Global Health-10
The Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS GH-10) is a 10-item patient-reported measure that assesses overall physical, mental, and social health. Items are scored on 5-point scales and combined to generate Global Physical Health and Global Mental Health scores. Higher scores indicate better overall health and well-being.
Time frame: From screening to the end of treatment at 12 weeks
Started Mar 2026 (actual). Primary completion is estimated for Jan 2027, 10 months after the start.
Of 1,092 interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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