The typically two-pronged approach to PTSD treatment of conversational therapy and/or prescription of symptom-managing medication has been the tried-and-true methodology for dealing with the often-debilitating condition, which claims countless lives each year and has long been a plague in the U.S.’s mental health epidemic. However, a new device that has raked in a pivotal FDA clearance has added a long-sought-after third option for dealing with PTSD.
Israel-based startup GrayMatters Health has developed a noninvasive neurostimulation device dubbed Prism that allows PTSD sufferers to essentially “retrain” their brain to both control and mitigate the symptoms associated with the condition. Thanks to the FDA’s recent thumbs up, Prism is a pioneer in becoming the first neuromodulation system of its kind to receive approval as an adjunct PTSD treatment.
The system is built on an EEG-fMRI-Pattern mechanism (EFP), relying on a range of electroencephalograms that hone in on the amygdala to create an EFP biomarker. In half-hour sessions, patients interact with Graymatters’ audio-visual software and are asked to find a mental strategy to help them remain calm in noisy and chaotic scenarios.
The FDA decision follows the submission of stellar results from a study of just under 80 chronic PTSD patients that confirmed the safety and efficacy of the Prism, although the exact findings have not yet been published. “Results demonstrated a high rate of symptom improvement, a low rate of adverse event and a low attrition rate,” said Dr. Charlie Marmar, the principal investigator in the study, which was conducted 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.”