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Recruiting NCT06770998

A Study of a Novel EEG Neurofeedback System for PTSD Treatment

Trial Parameters

Condition Stress Disorders, Post-Traumatic
Sponsor Foundation for Atlanta Veterans Education and Research, Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 250
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-05-14
Completion 2027-06
Interventions
EEG-neurofeedback trainingSham training

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)

Eligibility Criteria

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 interview instrument for DSM-5 psychiatric disorders with good test-retest reliability (Tolin et al. 2018); 4. Diagnosis of PTSD based on CAPS-5-R (scored as CAPS-5) total score with a minimum severity score of 26 at Baseline in the CAPS-5 score; 5. 1-26 years from index trauma; 6. Ability to give signed informed consent according to the judgment of the site investigator; 7. Normal or corrected-to-normal vi

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