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

NCT07523685 | Recruiting FDA Device

• 1 other identifier: PTSD-US-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

PTSD - Post Traumatic Stress Disorder; Post Traumatic Stress Disorder; Post Traumatic Stress Disorders; Post-Traumatic Stress Disorder, PTSD; PTSD; 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); Adjunctive treatment of post traumatic stress disorder; gammaCore; VNS; peripheral nerve stimulation; brain stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  From baseline to 12 weeks post-treatment

Secondary Outcomes (2)

• Post-Traumatic Stress Disorder Checklist for DSM-5

  From screening to the end of treatment at 12 weeks

• Clinician Global Impressions- Improvement Scale

  From screening to the end of treatment at 12 weeks

Other Outcomes (1)

• Patient-Reported Outcomes Measurement Information System Global Health-10

  From screening to the end of treatment at 12 weeks

Study Arms (1)

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.

Device: non-invasive vagus nerve stimulation

Interventions

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.

Also known as: Gammacore, Vagus nerve stimulation

Non-invasive Vagus Nerve Stimulation Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Acacia Clinics: lead
• ElectroCore INC: collaborator
• Vagus Nerve Society: collaborator

Study Sites (1)

Acacia Research Center

Sunnyvale, California, 94087, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)