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Behavioural Intervention

tcVNS for PTSD (VNS in PTSD Trial)

N/A
Recruiting
Led By Doug J Bremner, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to three months
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether a treatment called transcutaneous cervical vagal nerve stimulation (tcVNS) can help people with PTSD by looking at changes in the brain and body before and after treatment.

Who is the study for?
This trial is for Veterans aged 18-75 with PTSD. It's not suitable for those with recent substance abuse, positive pregnancy, serious medical conditions, significant brain injury or history of certain mental illnesses like schizophrenia or bipolar I disorder.
What is being tested?
The study tests the impact of transcutaneous cervical vagal nerve stimulation (tcVNS) versus a sham (fake treatment) on brain function and PTSD symptoms in Veterans. Participants will use the tcVNS or sham at home twice daily for three months.
What are the potential side effects?
While specific side effects are not listed here, tcVNS may generally cause discomfort at the site of stimulation, headache, voice changes or coughing due to its action on the vagus nerve.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to three months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to three months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in PTSD symptoms
brain
Secondary study objectives
interleukin-6
sympathetic function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: tcVNSExperimental Treatment1 Intervention
Stimulation twice daily with transcutaneous Vagal Nerve Stimulation (tcVNS)
Group II: shamActive Control1 Intervention
stimulation with sham

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,666 Previous Clinical Trials
3,765,729 Total Patients Enrolled
Doug J Bremner, MDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

tcVNS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05517304 — N/A
Post-Traumatic Stress Disorder Research Study Groups: sham, tcVNS
Post-Traumatic Stress Disorder Clinical Trial 2023: tcVNS Highlights & Side Effects. Trial Name: NCT05517304 — N/A
tcVNS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05517304 — N/A
~32 spots leftby Jul 2026
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