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NCT Number: NCT07523685

Non-invasive Vagus Nerve Stimulation (nVNS) for 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.

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Key information

Conditions

PTSD Combat Disorders Mental Disorders PTSD - Post Traumatic Stress Disorder Post Traumatic Stress Disorder Post Traumatic Stress Disorder PTSD Post Traumatic Stress Disorders Post-Traumatic Stress Disorder, PTSD Post-traumatic Stress Disorder (PTSD) Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acacia Research Center

Sunnyvale, California, 94087, United States

Location status: Recruiting

Location contact

Clinical Research Coordinator

CONTACT

[email protected]

650-993-9397

Danielle DeSouza, PhD

PRINCIPAL_INVESTIGATOR

Noah DeGaetano, MD

SUB_INVESTIGATOR

Vivian Hoang

CONTACT

[email protected]

650-263-9010

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Non-Invasive Vagus Nerve Stimulation

Device

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: Gammacore, Vagus nerve stimulation

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Acacia Clinics

Industry

Collaborators

  • ElectroCore INC
  • Vagus Nerve Society

Registry information

Official study title

Non-invasive Vagus Nerve Stimulation (nVNS) for Adjunctive Treatment of Symptoms Associated With Post-Traumatic Stress Disorder (PTSD)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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