Non-invasive vagus nerve stimulation (gammaCore) for PTSD
Non-invasive Vagus Nerve Stimulation (nVNS) for Adjunctive Treatment of Symptoms Associated With Post-Traumatic Stress Disorder (PTSD)
This study will test whether the handheld gammaCore device, which delivers mild electrical stimulation to the vagus nerve through the neck, can help adults with PTSD reduce their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Acacia Clinics Industry-sponsored |
| Locations | 1 site (Sunnyvale, California) |
| Trial ID | NCT07523685 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–70 with a clinician-confirmed PTSD diagnosis by SCID, a CAPS-5 score ≥35, and who are either off PTSD medications or on a stable PTSD medication regimen for at least three months and who have a primary psychiatric clinician.
Not a fit: Patients with unstable psychiatric or cognitive disorders, those below the CAPS-5 threshold, or those unable to keep PTSD medications stable are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this could offer a non-drug, at-home option to reduce PTSD symptoms using a handheld vagus nerve stimulator.
How similar studies have performed: Some small pilot studies and preclinical work suggest vagus nerve stimulation can modulate stress pathways, but clinical evidence for non-invasive VNS in PTSD is limited and preliminary.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Sunnyvale, California
- Acacia Research Center — Sunnyvale, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.