RecruitingNot ApplicableNCT06770998

A Study of a Novel EEG Neurofeedback System for PTSD Treatment

A Prospective Randomized Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers

Sponsor

Foundation for Atlanta Veterans Education and Research, Inc.

Enrollment

250 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

Stress Disorders, Post-Traumatic

Summary

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)

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new EEG neurofeedback system as a treatment for post-traumatic stress disorder (PTSD). Neurofeedback is a type of brain training where real-time information about your brainwaves is used to help you learn to regulate your own brain activity, without medication. **You may be eligible if...** - You are 18–65 years old with a confirmed diagnosis of PTSD - You have not completed a successful course of trauma-focused behavioral therapy in the past year - You are willing to participate in the study sessions **You may NOT be eligible if...** - You completed a trauma-focused therapy program in the past year that did not improve your PTSD - You have a medical device implanted (e.g., pacemaker) that could interfere with EEG - You have an active substance use disorder or other condition that would interfere with the study - You have severe, unstable psychiatric conditions in addition to PTSD - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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