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Vagus Nerve Stimulation

Non-Invasive Vagus Nerve Stimulation for PTSD

Phase 1 & 2
Recruiting
Led By Imanuel R Lerman, MD MSc
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male subjects between 21 and 65 years, any race or ethnicity
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up whodas 2.0: [time frame: baseline to week 1 of 1x daily treatment and post treatment week 5)]
Awards & highlights

Study Summary

This trial will study if non-invasive vagus nerve stimulation can help improve symptoms of PTSD in veterans.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of nVNS may include discomfort at the stimulation site on the neck, headache, voice changes due to muscle activation near vocal cords during stimulation; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man aged between 21 and 65.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~whodas 2.0: [time frame: baseline to week 1 of 1x daily treatment and post treatment week 5)]
This trial's timeline: 3 weeks for screening, Varies for treatment, and whodas 2.0: [time frame: baseline to week 1 of 1x daily treatment and post treatment week 5)] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neural Effects Measured by Functional MRI
Peripheral Blood Inflammatory Cytokine Measurement
Secondary outcome measures
Clinician Administered PTSD Scale
Sheehan Disability Scale (SDS)
WHODAS 2.0

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Transcutaneous Vagus Nerve StimulationActive Control1 Intervention
Cervical Transcutaneous vagus nerve stimulation. Participants will undergo once daily cervical transcutaneous vagus nerve stimulation.
Group II: Sham Vagus Nerve StimulationPlacebo Group1 Intervention
Sham Cervical Transcutaneous Vagus Nerve Stimulation. Participants will undergo once daily sham cervical transcutaneous vagus nerve stimulation.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,365 Total Patients Enrolled
Imanuel R Lerman, MD MScPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA

Media Library

Cervical Transcutaneous Vagus Nerve Stimulation (Vagus Nerve Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03858985 — Phase 1 & 2
Post-Traumatic Stress Disorder Research Study Groups: Transcutaneous Vagus Nerve Stimulation, Sham Vagus Nerve Stimulation
Post-Traumatic Stress Disorder Clinical Trial 2023: Cervical Transcutaneous Vagus Nerve Stimulation Highlights & Side Effects. Trial Name: NCT03858985 — Phase 1 & 2
Cervical Transcutaneous Vagus Nerve Stimulation (Vagus Nerve Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03858985 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment ongoing for this experiment?

"That is correct. According to clinicaltrials.gov, the trial posted on February 4th 2019 and updated in March 17th 2022 is actively recruiting patients; 88 are needed from one site."

Answered by AI

What are the criteria for enrolling in this clinical investigation?

"This clinical test is open to 88 individuals aged 21 to 65, who have some form of inflammation. In addition, the following criteria must be met: Males between 21 and 65 years old from any background; previous deployment experience with a traumatic event plus Clinician-Administered PTSD Scale for DSM-5 (CAPS -5) symptom cluster severity criteria that score above 33 on CAPS total cut off; failure to meet CAPS - 5 symptoms clusters severity critera scoring below 20 on the CAPS total cut off; capability in adhering to study schedule and procedures along with English fluency; being able to voluntarily provide written informed consent"

Answered by AI

To what extent has this clinical trial attracted participants?

"Affirmative. Per the details available on clinicaltrials.gov, this medical study is actively recruiting participants as of now. It was initially posted on April 2nd 2019 and has since been updated March 17th 2022. 88 prospective patients must be recruited for 1 centre to commence the trial."

Answered by AI

Can individuals aged 85 and above participate in this research experiment?

"According to the requirements of this medical trial, patients must be between 21 and 65 years old. Separately, there are 27 trials that accept participants under 18 and 265 studies open to seniors aged over 65."

Answered by AI
~13 spots leftby Mar 2025