The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents

Prism is a software as a medical device (SaMD) to be prescribed by clinicians as an adjunct to the standard of care treatment of patients with PTSD. The Prism software device runs on a laptop using an EEG signal input (g).Nautilos PRO (K171669). The primary objective of the study is to extend the use of the FDA cleared Prism for PTSD (K222101) to an adolescent population and to confirm the safety of fifteen (15±3) EEG-NF training sessions using the Prism software in reducing PTSD-related symptoms in adolescents. The study aims to demonstrate the safety profile of Prism, having no device-related serious adverse events (SAEs), consistent with findings in the adult population, throughout the course of Prism treatment in an adolescent population.

This study will be a Prospective, Single Arm, Open Label Trial, aiming to confirm the safety of the Prism system, adjunct to the standard of care, in adolescent subjects with PTSD. Up to 45 subjects, but not less than 35, will be enrolled, and all will undergo Prism neurofeedback training. Participants will complete 15(±3) neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks. A mid-training assessment will take place after 7 neurofeedback training sessions (week 4) and at the end of the training regimen (after completing the 15 ± 3 neurofeedback training - Week 8-9). A follow-up assessment will occur one (1) month after completing the last Prism training session.