NCT06770998

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Foundation for Atlanta Veterans Education and Research, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
DEVICE	EEG-neurofeedback training	15 training sessions (twice/week) plus two booster training sessions added to treatment as usual.
DEVICE	Sham training	15 sham sessions (twice/week) plus two sham booster sessions added to treatment as usual.

Timeline

• Start date: 2025-05-14
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2025-01-13
• Last updated: 2026-04-01

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study