Could a neck device tame PTSD symptoms?
NCT ID NCT07523685
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a handheld device called gammaCore that gently stimulates the vagus nerve in the neck, aiming to reduce PTSD symptoms. About 40 adults with PTSD will use the device at home for 12 weeks. Researchers will track symptom changes and safety to see if this approach could become a new treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- non-invasive vagus nerve stimulation device (gammaCore)
- What this could lead to
- If it works, this could offer a new, drug-free way to reduce PTSD symptoms that people can use at home.
- What could go wrong
- This is a small, early pilot study with no placebo group, so results may not be conclusive. The device is not yet approved for PTSD, and benefits may be modest.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Post traumatic stress disorder PTSD are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Acacia Research Center
RECRUITINGSunnyvale, California, 94087, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Five sessions to quiet trauma nightmares in bipolar disorder
- Can training hospital staff in Trauma-Informed care make childbirth safer?
- Scientists probe brain's reward system in mental illness
- Can a mindfulness class help veterans with concussion and PTSD?
- Can MDMA plus therapy help veterans fight both PTSD and alcohol addiction?
- Can a personalized mix of nerve stimulation and therapy rewire the brain for better mental health?