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Behavioural Intervention

Vagal Nerve Stimulation for Traumatic Brain Injury and PTSD (VNS mTBI 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
Veterans with mTBI and PTSD
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three months
Awards & highlights

VNS mTBI Trial Summary

This trial will study a new intervention for Veterans with mild traumatic brain injury and posttraumatic stress disorder.

Who is the study for?
This trial is for Veterans with mild traumatic brain injury (mTBI) and PTSD. Participants must not have had amnesia for over 24 hours post-event, a low Glasgow Coma Scale score, or loss of consciousness exceeding 30 minutes. They should be free from serious neurological disorders other than mTBI, active substance abuse, major psychiatric conditions like schizophrenia or bipolar disorder, significant medical illnesses, suicidal ideation, and certain medication treatments.Check my eligibility
What is being tested?
The study tests non-invasive Vagal Nerve Stimulation (nVNS) against sham stimulation to see its effects on memory and symptoms in Veterans with mTBI and PTSD. It will also assess changes in brain function and overall physiology resulting from the treatment.See study design
What are the potential side effects?
While specific side effects are not detailed here, nVNS may cause discomfort at the stimulation site, headache, voice changes due to nerve activation or involuntary muscle movements. Sham stimulation typically has no side effects but can include placebo responses.

VNS mTBI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a veteran with mild traumatic brain injury and PTSD.

VNS mTBI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline versus three months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline versus 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
CAPS
Change in IL6 Concentration in Blood with Stress
HVLT-R % retention
+2 more
Secondary outcome measures
PPG amplitude

VNS mTBI Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: nVNSExperimental Treatment1 Intervention
non invasive vagal nerve stimulation
Group II: shamPlacebo Group1 Intervention
sham stimulation

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,905 Total Patients Enrolled
Atlanta VA Medical CenterFED
26 Previous Clinical Trials
69,335 Total Patients Enrolled
Doug J Bremner, MDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

nVNS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04437498 — N/A
Traumatic Brain Injury Research Study Groups: sham, nVNS
Traumatic Brain Injury Clinical Trial 2023: nVNS Highlights & Side Effects. Trial Name: NCT04437498 — N/A
Traumatic Brain Injury Patient Testimony for trial: Trial Name: NCT04437498 — N/A

Frequently Asked Questions

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

What potential hazards can arise from using non-invasive vagus nerve stimulation?

"Our team at Power has rated the safety of nVNS as a 3, due to it having received approval from phase 4 trials."

Answered by AI

How many participants is the maximum capacity of this clinical research?

"Affirmative. Data from clinicaltrials.gov supports the active recruitment of patients for this medical trial, which was initially announced on February 25th 2021 and updated lastly on February 25th 2022. The goal is to recruit 100 participants at one location."

Answered by AI

Who is eligible to enroll in this trial?

"This research is recruiting 100 individuals aged 18 to 55 with PTSD. Notably, veterans who have experienced mild traumatic brain injury and post-traumatic stress disorder are encouraged to apply."

Answered by AI

Are any individuals over 45 permitted to partake in this study?

"Eligibility for this trial restricts potential participants to those between 18 and 55. Notably, there are 95 studies available for minors under the age of 18 and 459 research projects targeting individuals above 65 years old."

Answered by AI

Are new participants being admitted to this clinical assessment?

"Affirmative. Per information present on clinicaltrials.gov, this research project is presently accepting participants; it was first posted in February 2021 and recently revised in 2022 with the goal of recruiting 100 people from 1 centre."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Colorado
Florida
How old are they?
18 - 65
What site did they apply to?
Atlanta VA Medical and Rehab Center, Decatur, GA
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Still struggling with PTSDafter 20yrs. Hoping I can get some health before I do something I'll regret... Please help!
PatientReceived 2+ prior treatments
Destroyed family relationships including minor children, Gullible to wrong people, impulsive life choices, impulsive comments, anger, depression, impulsive financial decisions, cannot get along with co-workers, easily influenced by men or enablers, hints of suicide over years. All mentioned need help to stop.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is this a paid clinical trial?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Atlanta VA Medical and Rehab Center, Decatur, GA: < 48 hours
Average response time
  • < 2 Days
~31 spots leftby Sep 2025