Vagus Nerve Stimulation for PTSD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Acacia Clinics

Must not be taking: Rapid-acting antidepressants

Disqualifiers: Suicidal risk, Major medical illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to provide written informed consent

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.)

CAPS-5 score ≥ 35

Exclusion Criteria

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)

I do not have any major medical or neurological illnesses that would interfere with the study.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants complete a 4-week baseline period in which their PTSD symptoms are monitored

4 weeks

1 visit (in-person or remote)

Treatment

Participants use the gammaCore device at home for 12 weeks, applying it to the side of the neck for short stimulation sessions each day

12 weeks

6 visits (in-person and remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person or remote)

What Are the Treatments Tested in This Trial?

Interventions

• gammaCore

How Is the Trial Designed?

Group I: Non-invasive Vagus Nerve Stimulation Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Acacia Clinics

Lead Sponsor

ElectroCore INC

Industry Sponsor

Trials

31

Recruited

2,200+

Vagus Nerve Society

Collaborator