Actively Recruiting
A Prospective Randomized Study of a Novel EEG Neurofeedback System Using Machine Learning-Based Amygdala Biomarkers for PTSD Treatment
Led by Foundation for Atlanta Veterans Education and Research, Inc. · Updated on 2026-04-01
250
Participants Needed
6
Research Sites
8 weeks
Total Duration
On this page
Sponsors
F
Foundation for Atlanta Veterans Education and Research, Inc.
Lead Sponsor
G
GrayMatters Health Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether Prism training, a type of EEG neurofeedback using machine learning-based amygdala biomarkers, can reduce symptoms of post-traumatic stress disorder (PTSD) in U.S. military Veterans and civilians. This study compares Prism training to a sham training that mimics the experience but does not provide real brain feedback, aiming to see if adding Prism to usual PTSD treatment helps decrease symptoms. The trial is prospective, randomized, and double-blinded, sponsored by the Foundation for Atlanta Veterans Education and Research, Inc. Participants will undergo 15 in-person training sessions lasting about one hour each, held twice a week over approximately eight weeks. After this main training, two booster sessions occur one month and two months later. One group receives active Prism EEG neurofeedback training, while the other group receives sham training. Both trainings are added to participants' usual PTSD care. During the study, participants will complete three detailed interviews: before starting training, after nine weeks of training, and one month following the last booster session (around 20 weeks from the start). Researchers will measure changes in PTSD symptoms using the CAPS-5-R score from enrollment to week 9 and again at week 20. The study includes monitoring vision and hearing, adherence to the schedule, and stable medication use. Participants are followed for about 20 weeks in total.
CONDITIONS
Brief Title
A Study of a Novel EEG Neurofeedback System for PTSD Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 65 years
- Any gender including male, female, and gender-nonconforming
- Diagnosis of PTSD confirmed by clinical chart review and structured interview
- CAPS-5-R total score of at least 26 at baseline
- Trauma occurred between 1 and 26 years ago
- Ability to provide signed informed consent
- Normal or corrected vision of at least 20/30
- Normal or corrected hearing
- Willingness and ability to follow the study schedule
- Comorbid major depression allowed if PTSD is primary diagnosis
- Psychotropic medication stable for at least 4 weeks before screening
- No planned changes to medication or psychotherapy during study
You will not qualify if you...
- Previous trauma-focused therapy in past year without symptom improvement
- Lifetime diagnosis of schizophrenia, schizoaffective, schizophreniform, bipolar I or II, psychosis NOS, or delusional disorder
- Mood or anxiety disorder as primary focus of treatment in last 6 months
- Intellectual disability with IQ below 70
- Moderate or severe substance use disorder within 3 months
- Use of benzodiazepines that cannot be stopped or replaced prior to training
- Suicidal behavior or significant suicidality in last 6 months
- Starting cognitive behavioral therapy or PTSD psychotherapy within 3 months
- Significant neurological history or brain injury
- Moderate or severe traumatic brain injury or brain imaging showing damage
- Unstable medical conditions
- Psychiatric hospitalization in last 6 months
- Participation in another interventional clinical trial recently or during this study
- Pregnancy at 20 weeks or later at baseline
- COVID-19 infection symptoms within 2 months before screening
- Under criminal investigation or pending legal charges with possible incarceration
- Lack of stable contact information
- Working night shifts between midnight and 6 AM during study
- Narcolepsy
- Having a legally authorized representative
- Positive urine test for illegal substances other than marijuana
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 weeks
Participants receive 15 training sessions twice per week plus two booster training sessions as part of their assigned treatment.
Twice-weekly visits for 8 weeks plus 2 booster sessions at Week 12 and Week 16
Trial Site Locations
Total: 6 locations
1
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35210
Actively Recruiting
2
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Actively Recruiting
3
Boston VA Healthcare System
Boston, Massachusetts, United States, 02130
Actively Recruiting
4
New York University Grossman School of Medicine
New York, New York, United States, 10016
Actively Recruiting
5
University of Rochester Medical Center (URMC)
Rochester, New York, United States, 14623
Actively Recruiting
6
Charleston VA Medical Center
Charleston, South Carolina, United States, 29403
Actively Recruiting
Research Team
D
David Parker, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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