A Prospective Randomized Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers
Foundation for Atlanta Veterans Education and Research, Inc.
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
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria Subjects must meet the following inclusion criteria: 1. Ages 18 to 65 (older limit to avoid those with potentially reduced brain plasticity due to age); 2. Male, female, and gender-nonconforming subjects will be allowed. Sites will make efforts to enroll both male and female subjects in roughly equal proportions; 3. Diagnosis of PTSD comorbidities will be confirmed by clinical chart review and structured interview with the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders (DIAMOND), a semi-structured diagnostic intervie…
Interventions
- DeviceEEG-neurofeedback training
15 training sessions (twice/week) plus two booster training sessions added to treatment as usual.
- DeviceSham training
15 sham sessions (twice/week) plus two sham booster sessions added to treatment as usual.
Locations (6)
- Birmingham VA Medical CenterBirmingham, Alabama
- Atlanta VA Medical CenterDecatur, Georgia
- Boston VA Healthcare SystemBoston, Massachusetts
- New York University Grossman School of MedicineNew York, New York
- University of Rochester Medical Center (URMC)Rochester, New York
- Charleston VA Medical CenterCharleston, South Carolina