RecruitingNot ApplicableNCT06854328

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

A Prospective, Single Arm, Open Label Trial, to Confirm Safety and Effectiveness of Prism, as an Adjunct to Standard of Care, in Adolescents With Post-Traumatic Stress Disorder (PTSD)


Sponsor

GrayMatters Health Ltd.

Enrollment

45 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 12 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new therapy called "Prism Conformity" for treating PTSD in adolescents and young adults. It uses virtual reality and sensory techniques to retrain automatic fear responses linked to past trauma. **You may be eligible if:** - You are between 12 and 21 years old - You have been diagnosed with PTSD - It has been at least 1 year since the traumatic event - You can speak, read, and write in English - You have normal or corrected vision and hearing **You may NOT be eligible if:** - You have completed a full course of trauma-focused therapy before (e.g., EMDR or Prolonged Exposure) - You have been diagnosed with schizophrenia, bipolar I disorder, or a delusional disorder - You had a suicide attempt or serious self-harm in the past year - You are currently starting new psychiatric medications or are pregnant - You have a history of serious brain injury, seizures, or brain surgery - You have a moderate to severe substance use disorder in the past 3 months - You recently started CBT or another evidence-based PTSD therapy (within 3 months) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPrism

Prism is using an amygdala-fMRI-guided model for processing EEG signals. The model, termed EEG fMRI pattern (EFP), uses several electrodes EEG-signal to produce a real time amygdala-EFP biomarker signal. GrayMatters' product, Prism, is used to train patients in downregulating the amygdala-derived-EFP biomarker during therapy sessions.


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT06854328


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