Actively Recruiting
Non-invasive Vagus Nerve Stimulation (nVNS) for Adjunctive Treatment of Symptoms Associated With Post-Traumatic Stress Disorder (PTSD)
Led by Acacia Clinics · Updated on 2026-04-27
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
A
Acacia Clinics
Lead Sponsor
E
ElectroCore INC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the gammaCore non-invasive vagus nerve stimulation (nVNS) device as an additional treatment for adults with post-traumatic stress disorder (PTSD). The device may help regulate stress and emotional responses by stimulating the vagus nerve, which connects the brain to many body organs. This open-label pilot study aims to find out if regular use of the device at home can reduce PTSD symptoms and if it is safe for this purpose. Participants will first complete a 4-week baseline period without treatment to monitor their PTSD symptoms. Then, they will begin a 12-week treatment period using the gammaCore device at home, applying it to the side of the neck twice daily for about 2 minutes each time. Throughout the study, participants will attend six visits, some in person and some remotely, for training, assessments, and safety monitoring. During the study, participants will complete questionnaires and clinician assessments to measure PTSD symptoms and quality of life. Researchers will track any side effects or medical problems related to the device. The study will help understand whether non-invasive vagus nerve stimulation could be a useful treatment option for people living with PTSD.
CONDITIONS
Brief Title
Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID)
- CAPS-5 score of 35 or higher
- Between 18 and 70 years old
- Has PTSD symptoms and is either not taking PTSD medications or stable on PTSD medications for at least 3 months
- Agrees to avoid changing types or doses of certain medications that might interfere with the study
- Will use the nVNS device as instructed and follow all study requirements including visits
- Able to provide written informed consent
- Has a primary clinician responsible for psychiatric care before, during, and after the trial
You will not qualify if you...
- Psychiatric or cognitive disorders or behavioral problems that may interfere with the study, including suicidal or homicidal risk
- Major medical or neurological illnesses that interfere with the study based on exam or lab tests
- Cervical vagotomy or structural abnormalities at the nVNS treatment site
- Pain at the nVNS treatment site
- Implanted electrical or neurostimulator device such as pacemaker, vagal neurostimulator, or deep brain stimulator
- Pregnant, planning pregnancy, or unwilling to use birth control if of childbearing age
- Belongs to a vulnerable population or unable to consent or comply with study requirements
- Previous stellate ganglion block (SGB)
- Employee of the investigator or study site
- Recent or current use of rapid-acting antidepressants or other non-invasive stimulation therapies like TMS or ECT within 4 weeks prior to study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants undergo a 4-week baseline period without treatment to establish initial symptom levels.
Visits and symptom assessments during this period
Duration - 12 weeks
Participants self-administer non-invasive vagus nerve stimulation (nVNS) using the handheld gammaCore device twice daily at home to manage PTSD symptoms.
Study visits and symptom assessments throughout the treatment period
Trial Site Locations
Total: 1 location
1
Acacia Research Center
Sunnyvale, California, United States, 94087
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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