Prism for PTSD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: GrayMatters Health Ltd.

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

ADAR SHANI

Principal Investigator

GrayMatters Health

Eligibility Criteria

This trial is for adolescents with PTSD. Participants will use a software called Prism, which requires them to have EEG-NF training sessions. The goal is to see if it's safe and helps reduce PTSD symptoms in young people.

Inclusion Criteria

It has been over a year since my traumatic event.

I am under 18 and both I and my guardian agree to my participation.

I can speak, write, and read English.

Exclusion Criteria

Any unstable medical condition, as per the clinical judgement of the investigator

I have been diagnosed with a specific mental health condition.

I have moderate to severe ADHD symptoms.

Treatment Details

Interventions

• Prism (Behavioural Intervention)

Trial Overview Prism, a software used alongside standard PTSD treatments, is being tested on adolescents. It uses EEG signals to potentially aid in managing PTSD symptoms through fifteen training sessions.

Participant Groups

Group I: Single arm Experimental Treatment 1 Intervention

Eligible participants diagnosed with PTSD will be recruited from the community and from local clinical programs. All subjects will undergo Prism neurofeedback training. Participants will complete 15 neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks.

Who Is Running the Clinical Trial?

GrayMatters Health Ltd.

Lead Sponsor

Trials

4

Recruited

460+