Non-Invasive Vagus Nerve Stimulation for PTSD

AS
IR
Overseen ByImanuel R Lerman, MD MSc
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a non-invasive device that stimulates the vagus nerve can reduce PTSD symptoms, improve pain response, and enhance life quality for veterans. Participants will use a device on the neck daily, with effects compared to a similar device that does not actively stimulate the nerve. Veterans who have been deployed, experienced trauma, and face PTSD symptoms might be suitable candidates for this study. As a Phase 1/Phase 2 trial, the research aims to understand how the treatment works and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking PTSD treatment advancements.

Will I have to stop taking my current medications?

The trial requires that participants continue taking standard medications used to treat PTSD. However, if you take anti-inflammatory medications for chronic conditions or medications for chronic pain, you will be excluded from the trial.

What prior data suggests that this non-invasive vagus nerve stimulation is safe for PTSD?

Research has shown that cervical transcutaneous vagus nerve stimulation (tcVNS) is generally safe for people with PTSD. In past studies, patients handled the treatment well. One study found that tcVNS reduced certain stress-related inflammation without causing major side effects. Another study demonstrated that it helped lower stress responses in people with PTSD, suggesting its safety. While these studies show promising safety results, it is important to remember that this treatment is still under investigation. Further research could confirm its safety and effectiveness.12345

Why do researchers think this study treatment might be promising for PTSD?

Most treatments for PTSD involve psychotherapy or medications like SSRIs and SNRIs, which work by altering brain chemistry over time. However, cervical transcutaneous vagus nerve stimulation (tVNS) is different because it uses a non-invasive device to directly stimulate the vagus nerve through the skin on the neck. This method is unique because it could potentially modulate brain activity more directly and rapidly than traditional drugs. Researchers are excited about tVNS because it offers a new way to address PTSD symptoms without the side effects associated with medications, and it may provide faster relief than current therapeutic options.

What evidence suggests that this device is effective for PTSD?

Research has shown that cervical transcutaneous vagus nerve stimulation (tcVNS), a treatment participants in this trial may receive, might help people with PTSD by reducing stress. One study found that tcVNS lowered heart rates in people with PTSD, suggesting it helps calm stress. Another study indicated that tcVNS might improve attention and memory, potentially enhancing quality of life. Additionally, tcVNS has reduced the body's inflammatory response to stress. These findings suggest that tcVNS could help lessen PTSD symptoms and improve daily life.12367

Who Is on the Research Team?

IR

Imanuel R Lerman, MD MSc

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for male veterans aged 21-65 who have PTSD from deployment, with specific symptom severity scores. They must speak English and be able to follow the study schedule. Excluded are those with certain mental illnesses, recent evidence-based PTSD treatment, chronic pain management, risky alcohol/drug use, or conditions worsened by the treatment.

Inclusion Criteria

You have experienced a traumatic event, but your symptoms do not meet the severity criteria for a diagnosis of PTSD.
For PTSD: Previously deployed, experienced a traumatic event, and meets Clinician-Administered PTSD Scale for DSM-5(CAPS-5) symptom cluster severity criteria for PTSD diagnosis, as well as CAPS total cut-off score > 33
I am a man aged between 21 and 65.
See 2 more

Exclusion Criteria

You have taken part in another drug study or have been given experimental drugs within the last month.
I have not had major heart, artery, or neck issues, nor seizures or fainting in the past year.
I've had a head injury with unconsciousness over a minute and symptoms afterwards.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham transcutaneous vagus nerve stimulation daily for 7 days

1 week
7 visits (in-person)

Follow-up

Participants are monitored for changes in PTSD symptoms, functional life quality, and inflammatory biomarkers

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cervical Transcutaneous Vagus Nerve Stimulation
Trial Overview The study tests if non-invasive vagus nerve stimulation (nVNS) can change inflammation markers, brain response to pain stimuli in PTSD patients, and improve their symptoms and life quality. Participants will receive either active nVNS or a sham (fake) version as a comparison.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Transcutaneous Vagus Nerve StimulationActive Control1 Intervention
Group II: Sham Vagus Nerve StimulationPlacebo Group1 Intervention

Cervical Transcutaneous Vagus Nerve Stimulation is already approved in United States for the following indications:

🇺🇸
Approved in United States as VNS Therapy System for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

Transcutaneous Vagus Nerve Stimulation (tcVNS) significantly reduced PTSD symptoms by 31% compared to sham treatment over three months, indicating its potential efficacy as a therapeutic intervention.
tcVNS effectively blocked stress-induced increases in the inflammatory marker IL-6, suggesting that its mechanism of action may involve reducing inflammation associated with PTSD.
Transcutaneous Cervical Vagal Nerve Stimulation in Patients with Posttraumatic Stress Disorder (PTSD): A Pilot Study of Effects on PTSD Symptoms and Interleukin-6 Response to Stress.Bremner, JD., Wittbrodt, MT., Gurel, NZ., et al.[2023]
Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.
In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis.Kim, AY., Marduy, A., de Melo, PS., et al.[2023]
Transcutaneous cervical VNS (tcVNS) significantly reduces sympathetic responses to acute stress in patients with PTSD, as evidenced by decreased heart rate and improved vascular function during stress exposure.
The study involved 25 participants and demonstrated that tcVNS not only helps with stress related to traumatic memories but also has positive effects during mental stress, indicating its potential as a therapeutic intervention for PTSD.
Transcutaneous cervical vagal nerve stimulation reduces sympathetic responses to stress in posttraumatic stress disorder: A double-blind, randomized, sham controlled trial.Gurel, NZ., Wittbrodt, MT., Jung, H., et al.[2023]

Citations

Transcutaneous cervical vagal nerve stimulation reduces ...The purpose of this study was to assess the effects of transcutaneous cervical VNS (tcVNS) on autonomic responses to acute stress in patients with PTSD.
Effect of transcutaneous cervical vagus nerve stimulation ...These preliminary results suggest that tcVNS improves attention, declarative and working memory, which may improve quality of life and productivity for ...
Transcutaneous Vagal Nerve Stimulation in Veterans With ...This study effects the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) or a sham control on brain, physiology, and PTSD symptoms in Veterans ...
A Pilot Study of Effects on PTSD Symptoms and Interleukin-6 ...We previously showed that transcutaneous Vagus Nerve Stimulation (tcVNS) blocks inflammatory (interleukin (IL)-6) responses to stress in PTSD. The purpose of ...
Accrued reductions in heart rate following transcutaneous ...tcVNS induces accrued reductions in heart rate for participants with PTSD, potentially suggesting a temporary reduction of chronic cardiac arousal associated ...
Vagus nerve stimulation therapy for treatment-resistant PTSDVNS therapy was safe and feasible to deliver. •. After therapy, all participants no longer met the criteria for PTSD diagnosis. •.
Vagal Nerve Stimulation to Probe Inflammation and Brain ...Such outcomes may provide additional evidence of potential treatment efficacy, thus ultimately provide therapies that enhance VA clinical practice guidelines.
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