Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD)

April 22, 2026 updated by: Acacia Clinics

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sunnyvale, California, United States, 94087
        • Recruiting
        • Acacia Research Center
        • Sub-Investigator:
          • Noah DeGaetano, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Danielle DeSouza, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-invasive Vagus Nerve Stimulation Arm
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.
Other Names:
  • Vagus nerve stimulation
  • Gammacore

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the 12-week treatment period
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).
From baseline to 12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Traumatic Stress Disorder Checklist for DSM-5
Time Frame: From screening to the end of treatment at 12 weeks
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.
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
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.
From screening to the end of treatment at 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System Global Health-10
Time Frame: From screening to the end of treatment at 12 weeks
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.
From screening to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acacia Clinics

Collaborators

ElectroCore INC
Vagus Nerve Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTSD-US-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PTSD

Clinical Trials on non-invasive vagus nerve stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe