GrayMatters Health, a medtech company based in Israel, has developed Prism for PTSD, a self-neuromodulation therapy. The company has identified what they describe as brain-mechanism-specific biomarkers for certain mental disorders. These involve combining fMRI and EEG data. The Prism for PTSD system targets a specific biomarker called amygdala-derived-EFP, which is involved in the fight or flight response, and which can frequently be triggered in those with PTSD.
The new technique that GrayMatters Health developed involves applying an EEG cap to a patient’s head, and then placing them in front of a screen. An animation on the screen shows agitated people in a reception room. The system uses the patient’s EEG data to calculate a value for the amygdala-derived-EFP biomarker, and meanwhile the patient tries various mental strategies that may help to reduce the value. If a mental strategy works to reduce the biomarker, then the system will provide instant feedback to the patient and the agitated people in the animation will begin to sit down.
This type of neuro-feedback allows each patient to develop their own strategies to combat PTSD, and they can then apply these when they feel their symptoms arising out in the real world.
Medgadget had the opportunity to speak with Oded Kraft, Co-founder and CEO of GrayMatters Health, about the technology.
Conn Hastings, Medgadget: How is PTSD typically treated at present? Are these approaches effective?
Oded Kraft, GrayMatters Health: PTSD impacts nine million Americans, mostly women. Great progress has been made in PTSD treatment and management, yet, standard of care psychotherapy and drugs do not alleviate the symptoms for all patients. These treatments at times come with a long list of side effects, leaving many patients in search of an effective long-term solution. Of note, there are several PTSD focused modalities, such as PE, EMDR and tfCBT and others.
For some patients with PTSD, psychotherapy may not be an effective option, they may find talking about their traumatic experience stress inducing, untherapeutic or ineffective. While for other patients the possible adverse side effects from medication may prevent them from finding pharmacological therapies effective.
Alongside this, there is a shortage of mental health professionals in the United States, more than a third of the population live in areas with a lack of adequate mental health provision, leaving many patients in need of support.
Medgadget: What inspired this technology? How did the idea come about?
Oded Kraft: Prof. Talma Hendler, MD, PhD, the inventor of the core technology of Prism for PTSD, is both a psychiatrist and neuroscientist. Through her shared experience in both professions, she recognized the clear need for an alternative solution while also understanding the underlying mechanism behind the disorder. She started working on this technology around 2013 after realizing the dire need for an alternative solution for mental disorders, and through realization that science can provide more answers.
My co-founders and I met with Prof. Hendler in 2016 and we were fascinated with both her, the technology, and the paradigm shift we can drive with her in psychiatry. Throughout 2016 and until mid-2019 we conducted a deep technology due diligence, as well as market research, and met and spoke with dozens of mental healthcare providers. During this time, two additional studies ended successfully and were published, further validating the clinical safety and effectiveness.
At the end of the process, we concluded that there was a clear need, 66 million people live in the US with a mental disorder, and we could help them. We also decided that the technology was viable and scalable and should not be confined to treating a specific disorder, rather to the overall paradigm of mental healthcare therapy. We decided to start with Prism for PTSD before branching out to other mental disorders.
Medgadget: Please give us an overview of the digital self-neuromodulation therapies for mental disorders that have been developed by GrayMatters Health, or are in development.
Oded Kraft: GrayMatters Health is leveraging the EEG-fMRI Pattern (EFP) technology first developed by Prof. Hendler at the Tel Aviv Souraski Medical Center.
We have so far developed Prism for PTSD the first non-invasive, self-neuromodulation adjunct digital therapy for post-traumatic stress disorder. Prism for PTSD trains patients to lower the amygdala-derived-EFP biomarker associated with the emotional regulation system. The product will be available in the US this year as a prescription device, designed to fit into any clinic, administered under the direction of mental healthcare professionals.
Following the successful FDA clearance of this product, we are further developing the core EFP technology behind Prism for PTSD to address additional mental disorders. Our products will focus on treating Major Depressive Disorder, Attention Deficit Hyperactivity Disorder, General Anxiety Disorder and Borderline Personality Disorder. So, this is the first step in a long journey.
Medgadget: How does Prism for PTSD work? How far along is the technology in reaching clinical adoption?
Oded Kraft: Prism for PTSD uses a specific biomarker called amygdala-derived-EFP, which is associated with the emotion regulation system, what is referred to as the fight-flight-freeze instinct. Prism for PTSD therapy consists of 15 sessions spread over eight weeks, with each session lasting about 30 minutes. In each session, the mental healthcare professional places an EEG cap on the patient’s head and the patient sits in front of a screen showing a virtual scene of a reception room, where the avatars huddle around a reception desk and shout. The patient is then instructed to find a mental strategy, such as memory, emotion, or experience, that would make the avatars sit down. This method is known as neurofeedback – only here we are doing it on a specific biomarker.
As the patient practices different mental strategies, Prism for PTSD reads the EEG signal, uses it to compute the amygdala-derived-EFP, and uses that value to change what is happening in the user interface (i.e., reception room). As patients find the mental strategy that lowers the biomarker, the avatars sit, and the reception room becomes quieter. Think of it as placing a mirror in front of this specific brain activity. Over the course of the 15 sessions, patients practice this new skill and can improve with time.
Patients can also receive Prism for PTSD refresher sessions once the full course of treatment concludes, following the recommendation and prescription of the attending healthcare professional.
Following the conclusion of the treatment and any refresher sessions, patients can use these mental strategies in their daily lives. Through this treatment, we hope to provide patients with the tools to have more agency over their own healing, that will continue to evolve over time, all under the direction of a mental healthcare professional. Please note, the patient does not need to undergo a fMRI scan.
Prism for PTSD recently received 510(k) clearance from the FDA to market the product in the US. The product will be available to patients in the US starting later this year as a prescription device, designed to fit into any clinic, administered under the direction of mental healthcare professionals. We have already begun laying the groundwork for insurance coverage for Prism for PTSD, and have connected with top US payors to help patients gain access to adjunct digital therapy. If a healthcare professional is interested in using Prism at their clinic, they can be in contact with GMH.
Following the successful FDA clearance, GMH will also explore regulatory approvals in other markets.
Medgadget: How did you identify a biomarker of mental disorders? Please explain how this works.
Oded Kraft: Certain brain mechanisms are associated with different mental disorders. Based on the work of Prof. Hendler, GMH develops brain-mechanism-specific biomarkers named EEG-fMRI-Pattern (EFP). The biomarkers are developed by fusing data of electrical activity as measured on the scalp (measured with EEG), and blood flow signals of relevant brain mechanisms (as measured using fMRI scanners). Our product uses these biomarkers with an interactive audio/visual interface to help patients regain control (agency) over the relevant brain activity.
Prism for PTSD uses a specific biomarker called amygdala-derived-EFP, which is using data of the emotion regulation system. Scientific studies published prior to GMH’s inception have shown that PTSD is associated with increased amygdala activity which is why the biomarker we have developed focuses on this specific brain activity.
Medgadget: What are the next steps for the technology? Are you planning to release other technologies to assist those with different mental disorders in the future?
Oded Kraft: We plan to expand our clinical development to evaluate how the core technology can be applied to treat additional mental disorders including Major Depressive Disorder, Attention Deficit Hyperactivity Disorder, General Anxiety Disorder and Borderline Personality Disorder.
Looking further ahead, we plan to use deidentified data collected through Prism for PTSD treatments to develop treatment predictors, patient management tools and treatment personalization.
