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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

VNS in PTSD Trial 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.Check my eligibility

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.See study design

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.

VNS in PTSD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to three months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in PTSD symptoms

brain

Secondary outcome measures

interleukin-6

sympathetic function

VNS in PTSD 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,307,281 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

Frequently Asked Questions

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

Does this trial include elderly participants aged 75 or above?

"The age restrictions for this trial are as follows: the minimum eligibility threshold is 18 years old and the maximum is 75."

Answered by AI

What is the overall participant count for this clinical inquiry?

"Affirmative. Clinicaltrials.gov displays that this investigation is actively seeking volunteers, which was first posted on October 1st 2022 and most recently revised on the 7th of October 2022. 80 participants are necessary to be recruited from a single medical centre."

Answered by AI

Are there still vacancies for participants in this research project?

"Affirmative, the clinicaltrials.gov information reveals that recruitment is currently active for this medical study which commenced on October 1st 2022. The last update to the trial was made on October 7th and there are 80 patients being sought at a single site."

Answered by AI

Who is eligible to participate in this trial?

"To receive admittance to this medical trial, participants must have suffered moral injury and fall in the age range of 18-75. Altogether, 80 candidates are eligible for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

2022. "Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05517304.

All > Post Traumatic Stress Disorder > Ptsd