A Prospective Randomized Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Disorders, Post-Traumatic
- Sponsor
- Foundation for Atlanta Veterans Education and Research, Inc.
- Enrollment
- 250
- Locations
- 6
- Primary Endpoint
- Total CAPS-5-R score change from Baseline to Week 9
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief 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)
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Total CAPS-5-R score change from Baseline to Week 9
Time Frame: From enrollment to the end of 8 weeks' training (twice per week)
Participants will take the Clinician-Administered PTSD Scale for DSM-5 Revised (the CAPS-5-R) before beginning Prism training. The CAPS-5-R assesses PTSD symptom severity with total scores that range from 0-80, with higher scores indicating more severe symptoms. There are multiple ways to score the CAPS-5-R; this study will score the CAPS-5-R using the same 0-80 score range used on the CAPS-5 (the previous version of the same assessment) so that the results from this study can be more easily compared to results from previous studies on the Prism training system. Participants' scores on the CAPS-5-R after completing training will be compared to their pre-training scores to determine whether the Prism training group shows a greater reduction in PTSD symptoms than the Sham training group.
Secondary Outcomes
- Total CAPS-5-R score change from Baseline to Week 20(From enrollment to 20 weeks (including an initial 8 weeks of biweekly training and two booster sessions at Week 12 and Week 16))