The Study Results, Published in Psychiatry Research, Demonstrated a 67% Overall Response Rate and 32% Remission Rate
High Safety Profile Achieved with Mild and Temporary Side Effects
HAIFA, Israel and NEW YORK, Feb. 6, 2024 /PRNewswire/ — GrayMatters Health (GMH), developer of digital self-neuromodulation therapies for mental health care, announces the publication of a peer-reviewed article in the Journal of Psychiatry Research demonstrating the safety and efficacy of its FDA-cleared Prism for PTSD device. The prospective, single arm, multi-site, open label trial evaluated men, women, and treatment-resistant combat veterans with chronic post-traumatic stress disorder (PTSD).
Prism for PTSD is the first self-neuromodulation device to receive FDA clearance as a prescribed adjunct to standard-of-care for PTSD. The treatment, now available in select clinics in the United States, digitizes brain activity associated with PTSD to scientifically help patients gain control of their PTSD symptoms.
“The results demonstrated a high rate of symptom improvement, a low rate of adverse events and a low attrition rate,” said Professor Charlie Marmar, Principal Investigator of the study at NYU Langone. “I am encouraged that Prism, as an adjunctive therapy, will significantly benefit patients with PTSD and allow clinics to offer more options and better outcomes.”
The study enrolled 79 patients. The primary endpoint was met with a response rate of 67% for Clinician Administered PTSD Scale (CAPS-5) at three-month follow-up. The average reduction in CAPS-5 total scores was 13.5 points, demonstrating clinically meaningful improvement. Secondary outcomes including PTSD Checklist for DSM-5 (PCL-5) and Patient Health Questionnaire (PHQ-9) also demonstrated statistically and clinically significant improvement from baseline to eight weeks and three months. Moreover, 32% of patients achieved remission three months following completion of Prism treatment. The safety profile was high with only mild and temporary adverse events reported.
“Millions of Americans struggling with PTSD must navigate medication side effects, revisit traumatic experiences with psychotherapy or choose not to seek treatment due to societal stigma,” said Oded Kraft, CEO and Co-Founder of GMH. “These clinical results build on prior research and demonstrate that Prism offers patients living with PTSD an effective and safe pathway toward improved mental health.”
Prism’s core technology is the world’s first digital biomarker of brain activity associated with mental health disorders. The EEG-fMRI-Pattern (EFP) biomarker was developed by applying advanced statistical models to register fMRI amygdala data with EEG. This puts a neuroscience-based tool into the hands of clinicians to improve patient care. Prism for PTSD uses a computer simulation and EEG headset to create a novel, immersive environment for training individuals to self-modulate an amygdala-based biomarker associated with PTSD.
About GrayMatters Health
GrayMatters Health (GMH), develops self-neuromodulation therapies to enhance mental health care outcomes. GMH is the first company to develop a treatment based on digital biomarkers of brain-mechanism-specific activity associated with mental disorders. GMH’s flagship FDA-cleared product, Prism for PTSD, is an award-winning digital therapy offering providers a neuroscience-based technology that augments standard-of-care therapies while improving patient outcomes. The company is collaborating with leading mental health institutions to evaluate Prism for additional mental disorders.
GMH’s core patented technology has been extensively researched and featured in a variety of peer-reviewed publications, led by Professor Talma Hendler, MD, PhD and her team at Tel Aviv University. Learn more by visiting our website https://graymatters-health.com and following us on LinkedIn and X.
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SOURCE GrayMatters Health Ltd.
