A Study of a Novel EEG Neurofeedback System for PTSD Treatment

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

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.

Sponsors & Collaborators

• GrayMatters Health Ltd.

  collaborator INDUSTRY

• Rochester Institute of Technology

  collaborator OTHER

• NYU Langone Health

  collaborator OTHER

• Atlanta VA Medical Center

  collaborator FED

• Birmingham VA Health Care System

  collaborator FED

• Ralph H. Johnson VA Medical Center

  collaborator FED

• VA Boston Healthcare System

  collaborator FED

• CTP Inc

  collaborator UNKNOWN

• BioStats Statistical Consulting Ltd

  collaborator UNKNOWN

• ShareCRF

  collaborator UNKNOWN

• United States Department of Defense

  collaborator FED

• University of Rochester

  collaborator OTHER

• Foundation for Atlanta Veterans Education and Research, Inc.

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-14

Primary Completion

2027-06-30

Completion

2027-08-31

FDA Device

Yes

Countries

• United States

Study Locations