Non-Invasive Vagus Nerve Stimulation for PTSD
Trial Summary
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 data supports the effectiveness of the treatment Cervical Transcutaneous Vagus Nerve Stimulation for PTSD?
Is non-invasive vagus nerve stimulation safe for humans?
How does cervical transcutaneous vagus nerve stimulation (tcVNS) differ from other treatments for PTSD?
Cervical transcutaneous vagus nerve stimulation (tcVNS) is unique because it is a non-invasive treatment that targets the vagus nerve through the skin on the neck, aiming to reduce stress responses and inflammation in PTSD patients without the need for surgery or medication. This approach is different from traditional treatments like medications and psychotherapy, as it directly influences neurobiological systems involved in PTSD symptoms.12345
What is the purpose of this trial?
The proposal aims to determine if non-invasive vagus nerve stimulation(nVNS) will alter: 1) the peripheral inflammatory biomarker profile, 2) the neural correlates of change in pain stimuli and 3) PTSD symptom severity and 4) life quality and function in Veterans with PTSD. The planned inflammatory biomarker and neuroimaging results can 1) promote knowledge of inflammatory and neurobiological mechanisms that contribute to pain in PTSD, and 2) advance the ability to provide targeted neuromodulation based interventions that support improved life quality and function for Veterans. These goals are consistent with the VA's mission to sponsor research examining variables related to pathogenesis, diagnosis, and(ultimately) treatment of neuropsychiatric disorders.
Research Team
Imanuel R Lerman, MD MSc
Principal Investigator
VA San Diego Healthcare System, San Diego, CA
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active or sham transcutaneous vagus nerve stimulation daily for 7 days
Follow-up
Participants are monitored for changes in PTSD symptoms, functional life quality, and inflammatory biomarkers
Treatment Details
Interventions
- Cervical Transcutaneous Vagus Nerve Stimulation
Cervical Transcutaneous Vagus Nerve Stimulation is already approved in United States for the following indications:
- Treatment-resistant depression
- Epilepsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor