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

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Post-Traumatic Stress Disorder in Adolescence

Eligibility basics and study details

Study type

Interventional

Phase

Not applicable

Ages

12 to 21 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

GrayMatters Health Ltd.

Last updated on ClinicalTrials.gov

May 5, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites