40 Participants NeededMy employer runs this trial

Vagus Nerve Stimulation for PTSD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called gammaCore to determine if it can safely reduce PTSD (post-traumatic stress disorder) symptoms. The gammaCore device sends gentle electrical signals to the vagus nerve, which connects the brain to many parts of the body and helps control stress. Researchers aim to discover if regular home use of this device can improve PTSD symptoms. Individuals with a PTSD diagnosis who either do not take medication or have been stable on medication for three months might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new methods of managing PTSD symptoms.

Do I have to stop taking my current medications for the trial?

You don't have to stop your current PTSD medications if you've been stable on them for 3 months. However, you must not start or change any other medications that might interfere with the study, like antidepressants or beta-blockers, unless your clinician approves.

What prior data suggests that the gammaCore device is safe for treating PTSD?

Research has shown that the gammaCore device, which employs non-invasive vagus nerve stimulation (nVNS), is generally easy for people to use without issues. Studies have found that nVNS can significantly reduce stress-related reactions. Importantly, no serious side effects have been directly linked to this device. The FDA has already approved the gammaCore for treating migraines and cluster headaches, indicating its safety when used correctly for these conditions. While researchers continue to study nVNS for PTSD, its previous applications provide some reassurance about its safety.12345

Why are researchers excited about this trial?

Unlike traditional treatments for PTSD, which often involve medications like SSRIs, therapy, or a combination of both, gammaCore offers a non-invasive approach by using vagus nerve stimulation (nVNS). This device is handheld and applied to the side of the neck, delivering quick, two-minute stimulations twice a day that could potentially alleviate PTSD symptoms. Researchers are excited because this method targets the vagus nerve directly, which is believed to play a crucial role in regulating stress and mood, offering a novel mechanism of action with a convenient at-home treatment process.

What evidence suggests that the gammaCore device is effective for PTSD?

Research has shown that the gammaCore device, which uses a gentle electrical pulse to stimulate a nerve in the neck, may help reduce PTSD symptoms. Some studies have found it can improve attention, memory, and social skills in people with PTSD. Another study noted a decrease in stress-related brain activity, which might help ease trauma symptoms. Importantly, two trials reported that gammaCore had a positive effect on PTSD symptoms. The device already has FDA approval for treating migraines and cluster headaches, suggesting it could be a safe option. Overall, these findings suggest gammaCore might help manage PTSD symptoms. Participants in this trial will receive treatment with the gammaCore non-invasive vagus nerve stimulation device to assess its effectiveness for PTSD.12367

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 diagnosed with PTSD, who have stable symptoms and are either not taking or have been on the same PTSD medication for at least 3 months. Participants must be able to follow study instructions and cannot join if they have certain medical devices, major illnesses, pregnancy, or unstable living situations.

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
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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)
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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

Trial Overview

The study tests a handheld device called gammaCore that delivers gentle electrical stimulation to the vagus nerve through the skin of the neck. About 40 adults with PTSD will use this device daily at home for 12 weeks to see if it safely reduces their PTSD symptoms.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Non-invasive Vagus Nerve Stimulation ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Acacia Clinics

Lead Sponsor

ElectroCore INC

Industry Sponsor

Trials
31
Recruited
2,200+

Vagus Nerve Society

Collaborator

Citations

Non-invasive Vagus Nerve Stimulation (nVNS) for Post ...

The primary efficacy outcome is the change in total Clinician-Administered PTSD Scale (CAPS-5) score (a semi-structured clinical interview). From baseline to 12 ...

Non-invasive vagal nerve stimulation decreases brain activity ...

We hypothesize that non-invasive cervical vagal nerve stimulation (nVNS) may alleviate trauma symptoms by reducing stress sympathetic reactivity.

Non-invasive Vagus Nerve Stimulation in Post-Traumatic ...

The designation of nVNS as Breakthrough Devices underscore its potential to address unmet needs in PTSD management, offering hope for improved outcomes and ...

gammaCore Non-Invasive Vagus Nerve Stimulation (nVNS ...

Two prospective, peer reviewed trials demonstrate the symptomatic benefit of gammaCore in patients with PTSD. ROCKAWAY, N.J., Sept.

gammaCore (Non-Invasive Vagus Nerve Stimulation

This longitudinal study shows benefit for cognitive symptoms associated with PTSD and suggests that nVNS may improve work and social functioning for patients ...

nVNS for Treating the Symptoms of PTSD

nVNS led to significantly greater decreases in long-term heart rate variability over the course of multiple traumatic stress and stimulation protocols.

Vagus nerve stimulation therapy for treatment-resistant PTSD

We developed a fundamentally novel neuromodulation-based therapy for treatment-resistant PTSD. This approach is premised on coupling prolonged exposure therapy.