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)
GrayMatters Health Ltd.
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.
Description
This study will be a Prospective, Single Arm, Open Label Trial, aiming to confirm the safety of the Prism system, adjunct to the standard of care, in adolescent subjects with PTSD. Up to 45 subjects, but not less than 35, will be enrolled, and all will undergo Prism neurofeedback training. Participants will complete 15(±3) neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks. A mid-training assessment will take place after 7 neurofeedback training sessions (week 4) and at the end of the training regimen (after completing the 15 ± 3 neurof…
Eligibility
- Age range
- 12–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Ages 12 to 21 years. 2. Any gender. 3. Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). 4. ≥1 year since index trauma. 5. For candidate participants under 18 years old: Willingness and ability to provide assent, with the participant's legal guardian able and willing to provide informed consent for their study participation. 6. For candidate participants 18 years old and above: Willingness and ability to provide informed consent for their study participation. 7. English speaking, writing and rea…
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 (2)
- NYU Langone HealthNew York, New York
- Sheba Medical CenterRamat Gan