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Behavioural Intervention

Vagal Nerve Stimulation for Traumatic Brain Injury and PTSD (VNS mTBI Trial)

N/A
Recruiting
Led By Doug 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 between 18 and 65 years old
Must not have
Active neuroleptic, opiate, or benzodiazepine treatment
Meningitis or other neurological disorder other than mTBI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline versus three months
Awards & highlights

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication for my nerves, pain, or anxiety.
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I have a neurological condition that is not mild traumatic brain injury.
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I have a serious illness affecting my heart, stomach, liver, kidneys, brain, or other organs.

Timeline

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

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
1,647 Previous Clinical Trials
3,359,970 Total Patients Enrolled
Atlanta VA Medical CenterFED
26 Previous Clinical Trials
69,335 Total Patients Enrolled
Doug Bremner, MDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
3 Previous Clinical Trials
172 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
~22 spots leftby Sep 2025
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