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.

NCT Number	NCT06854328
Lead Sponsor	GrayMatters Health Ltd.
Conditions	Post-Traumatic Stress Disorder in Adolescence
Enrollment	45 participants
Start Date	2025-06-11
Primary Completion	2026-08-01 (estimated)
Study Completion	2026-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-05