tcVNS for Moral Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, GA
Moral Injury+2 More
tcVNS - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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. tcVNS is a treatment for Moral Injury that is specifically for veterans. In this trial, there will be no placebo group, meaning that all patients will receive the tcVNS treatment. This treatment has previously been approved by the FDA for a different condition.

Eligible Conditions

  • Moral Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Moral Injury

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Baseline to three months

Baseline to three months
Change in PTSD symptoms
baseline
brain
interleukin-6
sympathetic function

Trial Safety

Safety Progress

1 of 3

Other trials for Moral Injury

Trial Design

2 Treatment Groups

sham
1 of 2
tcVNS
1 of 2
Active Control
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: tcVNS · No Placebo Group · N/A

tcVNS
Device
Experimental Group · 1 Intervention: tcVNS · Intervention Types: Device
sham
Device
ActiveComparator Group · 1 Intervention: sham · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to three months
Closest Location: Atlanta VA Medical and Rehab Center, Decatur, GA · Decatur, GA
Photo of georgia 1Photo of georgia 2Photo of georgia 3
2009First Recorded Clinical Trial
0 TrialsResearching Moral Injury
41 CompletedClinical Trials

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,462 Previous Clinical Trials
2,749,141 Total Patients Enrolled
6 Trials studying Moral Injury
460 Patients Enrolled for Moral Injury
Doug J Bremner, MDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.