Prism Conformity Trial for PTSD in Adolescents
This study is testing a device called Prism for adolescents aged 12 to 21 who have Post-Traumatic Stress Disorder (PTSD). Prism is a software that uses brainwave signals (EEG) to help train patients to reduce their PTSD symptoms. The main goal of this study is to see if Prism is safe for adolescents and to confirm that it helps reduce PTSD symptoms, similar to what has been seen in adults. You could join if you are 12-21 years old, have a PTSD diagnosis for at least a year, and for those under 18, your legal guardian can give consent. The study is currently unclear on its recruitment status.
- Study design
- This is a single-arm, open-label study, meaning all participants will receive the Prism treatment, and everyone will know what treatment is being given. Up to 45 participants will be enrolled.
- What's involved
- Participants will complete 15 (plus or minus 3) neurofeedback training sessions with Prism, delivered twice a week over about 8 weeks. There will be assessments during and at the end of the training.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will have a follow-up assessment one month after their last Prism training session.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- ADAR SHANI · STUDY_DIRECTOR · GrayMatters Health
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety reporting1 month
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 Prism, by closely following and analyzing device-related serious adverse events. The success criterion is defined by no serious adverse event which is deemed as device-related during the study and one month after treatment ends.