GrayMatters Health, an Israeli company, is developing a noninvasive Neuromodulation Device to help PTSD patients retrain their brains to reduce and regulate their symptoms. The company recently announced that its Prism Technology has received FDA approval as an additional treatment option for PTSD.
Treatment for post-traumatic stress disorder (PTSD) usually involves talk therapy and medication to manage symptoms. Now, a new FDA-cleared technology called self-guided neuromodulation offers a third option. GrayMatters Health has received FDA clearance to commercialize its main product, a self-neuromodulation digital treatment for PTSD. The device applies neurofeedback on specific biomarkers to help patients identify and use their own mental techniques to reduce their emotional reactions.
The Prism system is based on the EEG-fMRI-Pattern mechanism, according to GrayMatters. To create a picture of the activity in the patient’s brain, a series of electroencephalograms and functional MRI scans are first performed, focusing on the amygdala, the brain’s emotional center. The data is then used to create a unique EFP biomarker for each patient.
The Prism treatment consists of 15 sessions, each lasting about 30 minutes, spaced out over an eight-week period. Each session starts with the patient sitting in front of a screen that displays a virtual waiting room while a mental healthcare practitioner places the EEG on the patient’s scalp. Avatars in the virtual space yell and crowd around the front desk.
After that, the Prism neuromodulation device, which is connected to a headset, receives the EFP model. Patients use the headgear twice a week in 30-minute sessions for about two months. They learn to recognize how certain situations and their reactions to those situations affect their brain signals during each session while interacting with audio-visual software created by GrayMatters.
Neurofeedback continually modifies the on-screen circumstances by comparing the patients’ real-time EEG data to their unique EFP models. The device’s idea is that patients will learn how to consciously control their brain waves after seeing visual evidence of how various stimuli affect their brain’s electrical activity.
The FDA approved the therapy based on research conducted by GrayMatters involving 79 people with persistent PTSD. The primary investigator at the study’s NYU Langone location, Charlie Marmar, M.D., said in this week’s statement that the trial’s findings verified the safety and effectiveness of the neuromodulation device, even though the results have not been made public.
The CEO of GrayMatters said: “Looking ahead, the company also plans to use deidentified data collected throughout Prism treatments to develop treatment predictors, patient management tools, and treatment personalization. This is as personalized as treatment can get. For example, one patient might find that thinking of a happy childhood memory helps lower their biomarker. Another patient might begin counting numbers and reach the same result.”
GrayMatters will start offering Prism to outpatient and private mental health clinics later this year. Psychologists and psychiatrists will be able to prescribe and administer Prism at these clinics, allowing patients to maintain their current PTSD treatment plans
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