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

Conditions

• Post-Traumatic Stress Disorder in Adolescence

Eligibility Criteria

Sex

ALL

Age

12 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Prism — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Jun 11, 2025

Status verified

Jun 2025

Primary completion

Aug 1, 2026

Completion

Nov 1, 2026

Study Design

Enrollment

45 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Single arm
  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.

Primary Outcome Measure

Safety reporting [ Time Frame: 1 month ]

Central Contacts

• Jennifer Yarden
  +972-524897823
  [email protected]

Locations (1)

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