Non-invasive vagus nerve stimulation (gammaCore) for PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses the gammaCore handheld non-invasive vagus nerve stimulation (nVNS) device as an add-on treatment for adults with PTSD. Participants aged 18–70 with a SCID-confirmed PTSD diagnosis and a CAPS-5 score of 35 or higher will use the device per protocol while keeping PTSD medications stable or remaining off PTSD medications for at least three months. The single-site trial in Sunnyvale, California will collect symptom measures and safety data at scheduled follow-up visits. Because gammaCore is FDA-cleared for migraine and cluster headache but not for PTSD, the study focuses on tolerability and symptom change in this population.

Why it matters

Who can join: the full rules

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)

Where it's running

• Acacia Research Center
  Sunnyvale, California, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.