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Non-invasive Vagus Nerve Stimulation (nVNS) for PTSD

This study is testing a device called gammaCore, which uses gentle electrical stimulation on the side of your neck, to see if it can help adults with Post-Traumatic Stress Disorder (PTSD). The gammaCore device stimulates the vagus nerve, which connects to your brain and helps regulate stress. Researchers want to find out if this device is safe and effective as an additional treatment for PTSD symptoms. You may be able to join if you are between 18 and 70 years old, have a PTSD diagnosis, and a CAPS-5 score of 35 or higher. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 40 participants. It is testing the gammaCore device as an additional treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures safety during the 12-week treatment period and PTSD symptoms from baseline to 12 weeks post-treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07523685

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

Recruiting
NAAges 18–70InterventionalTreatment
Acacia Clinics
~40 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:non-invasive vagus nerve stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serious Adverse Events (SAEs)
Measured over During the 12-week treatment period
+1 more outcome measured

Conditions

PTSD
Post Traumatic Stress Disorder PTSD
PTSD - Post Traumatic Stress Disorder
Post Traumatic Stress Disorder
Post Traumatic Stress Disorders
Post-traumatic Stress Disorder (PTSD)
Post-Traumatic Stress Disorder, PTSD

Explore related trials

Post-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
California1

Who to contact

Clinical Research Coordinator
[email protected]
650-993-9397
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Serious Adverse Events (SAEs)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.

  • Clinician Administered PTSD Scale (CAPS-5)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).