Actively Recruiting
The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents
Led by GrayMatters Health Ltd. · Updated on 2026-05-05
45
Participants Needed
2
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 12 to 21 years
- Any gender
- Diagnosis of PTSD according to DSM-V
- At least 1 year since the traumatic event
- For participants under 18: able to assent and have a legal guardian provide consent
- For participants 18 and older: able to provide informed consent
- Able to speak, read, and write English
- Normal or corrected vision and hearing
You will not qualify if you...
- Completed one or more full courses of trauma-focused therapy previously
- Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder
- Primary treatment for any mood or anxiety disorder in the past 6 months
- Autism spectrum disorder requiring substantial support or mild intellectual disability
- Moderate or severe substance use disorder in the past 3 months
- Moderate or severe ADHD symptoms currently
- Changed or started psychotropic medications in the past 4 weeks or plans to change during study
- Suicidal behavior within the past year
- Started cognitive-behavioral or PTSD psychotherapy within the past 3 months
- History of brain surgery, major brain injury, epilepsy, or major neurological issues
- Unstable medical conditions
- Enrolled in another interventional clinical study within 2 months prior or during this study
- Female participants who are pregnant, nursing, or planning pregnancy during the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
2
Sheba Medical Center
Ramat Gan, Israel, 3303403
Actively Recruiting
Research Team
J
Jennifer Yarden
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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