Actively Recruiting
A Study of a Novel EEG Neurofeedback System for PTSD Treatment
Led by Foundation for Atlanta Veterans Education and Research, Inc. · Updated on 2026-04-01
250
Participants Needed
6
Research Sites
115 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
The goal of this clinical trial is to learn if training with the Prism system can reduce PTSD symptoms in US military Veterans and civilians with PTSD. Prism is a form of neurofeedback training that uses EEG signals to promote self-regulation of brain function. The main question this study aims to answer is: Does Prism training lead to decreased PTSD symptoms in US Veterans and civilians when used in addition to usual PTSD treatment? Researchers will compare Prism training to a sham training (a look-alike training that does not provide real feedback on brain activity) to see if Prism training decreases PTSD symptoms. Participants will: * Complete two one-hour in-person training sessions a week for about 8 weeks (15 sessions) * Complete two booster training sessions one month and two months after finishing the main training course * Participate in three detailed interviews: one before training, a second after nine weeks of training, and a third one month after the last booster training session (about 20 weeks after the initial visit)
CONDITIONS
Official Title
A Study of a Novel EEG Neurofeedback System for PTSD Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Male, female, or gender-nonconforming individuals
- Diagnosis of PTSD confirmed by clinical chart review and structured interview
- Minimum PTSD severity score of 26 on CAPS-5-R at baseline
- Between 1 and 26 years from the traumatic event
- Ability to give signed informed consent
- Normal or corrected vision of at least 20/30
- Normal or corrected hearing based on report and interview
- Willingness and ability to follow the study schedule
- Comorbid major depression allowed if PTSD is primary care focus
- Stable psychotropic medication dose for at least 4 weeks prior to screening
- No planned changes to medication or psychotherapy during the study if applicable
You will not qualify if you...
- Completed trauma-focused behavioral therapy in past year without PTSD symptom improvement
- Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I or II disorder, psychosis not otherwise specified, or delusional disorder
- Primary focus of treatment is a DSM-5 mood or anxiety disorder other than PTSD in past 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 substituted prior to training
- Suicidal behavior or significant suicidality in last 6 months
- Begun cognitive behavioral therapy or PTSD psychotherapy within 3 months
- Significant neurological or neurosurgical history, brain injury, epilepsy, or cognitive impairment
- History of moderate or severe traumatic brain injury or structural brain damage
- Unstable medical condition
- Psychiatric hospitalization in last 6 months
- Enrolled in another interventional study within 2 months or during this study
- Pregnancy at 20 weeks or later at baseline
- Acute COVID-19 infection symptoms at screening or 2 months prior
- Under criminal investigation or pending legal charges with possible incarceration
- Lack of stable contact information
- Working midnight to 6 AM during study
- Narcolepsy
- Has a Legally Authorized Representative
- Positive urine toxicology for illegal substances except marijuana
AI-Screening
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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
CONTACT
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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