Source: Courtesy of GMH

The trauma of posttraumatic stress disorder (PTSD) is both personal and social. The condition affects approximately 3.5 percent of U.S. adults every year and the prevalence of the condition in adolescents is 8 percent. Further, it’s been estimated that one in 11 people will be diagnosed with PTSD in their lifetime, and women are twice as likely as men to have PTSD.

Until recently, PTSD standard-of-care treatment primarily focused on two areas—pharmacotherapy and psychotherapy. These treatment modalities have proven effective for many patients, and, yet, PTSD is a unique journey for every patient, each of whom needs specialized treatment plans to meet their needs. Often, cognitive therapy requires a patient to revisit the causative traumas, which can be emotionally challenging for the patient.

An important therapeutic target

The amygdala is a small, almond-shaped structure located deep within the brain's temporal lobes. It plays a crucial role in the processing of emotions, particularly fear and anxiety. In PTSD, the amygdala is often implicated due to its involvement in the formation and retrieval of emotional memories, as well as its role in the fear response.

There are thousands of published studies indicating the amygdala’s role in mental health. The amygdala—the control center of the fight-flight-freeze response—has been clinically proven to play a significant role in PTSD. Until now, no drug, medical device, or behavioral treatment focuses exclusively on the amygdala. This is because existing technologies that could support the volitional control of the amygdala have been limited.

Non-invasive downregulation for direct symptom control

GrayMatters Health (GMH) has created a biomarker of brain-mechanism-specific activity known as the EEG-fMRI Pattern (EFP) biomarker that establishes an amygdala-fMRI-guided model for processing EEG signals. The newly FDA-approved system, called Prism, uses several electrodes to produce a real-time amygdala-derived-EFP biomarker signal to train patients in downregulating the amygdala-derived-EFP biomarker during neurofeedback. The EFP model was embedded in Prism forming an EEG neurofeedback device (no fMRI needed) used to train patients to directly regulate the EFP biomarker signal. The data used for the FDA submission and approval is currently under submission to a peer-reviewed journal and embargoed.

Eyal Fruchter, MD, director of mental health at Rambam Hospital and former head of the mental health division in the Israeli Medical Corps, said, "Prism offers a non-pharmacologic path forward without the need to re-experience traumatic memories."

During treatment sessions, Prism conducts neurofeedback via an EEG cap to measure the EFP biomarker while patients interact with an audio/visual interface, in which avatars are huddled around the reception desk at a medical facility, shouting at the receptionists. Patients are instructed to find a mental strategy personal to them—such as a memory, emotion, or experience—to quiet the avatars. As patients find a technique that lowers their EFP biomarker, the virtual scene changes in response. Therapy includes 15 30-minute sessions, conducted twice a week for a period of eight weeks. Prism is designed to fit at any clinic. Notably, as an adjunct therapy, patients using Prism for PTSD can maintain existing treatment regimens and use Prism to augment treatment responses.

Filling a therapeutic gap

There is also a shortage of mental health care professionals across the United States. Despite the rising rates in mental disorders, there are not enough mental health professionals in the country to keep up with the demand. This crisis is most acute for the 163 million Americans living in federally designated mental health professional shortage areas, with the latest statistics demonstrating a need for more than 8,200 mental health care practitioners to fill the gap.

The development of Prism, a noninvasive and amygdala-focused treatment for PTSD, represents new approach for the management of PTSD and it will be important to see how long-term efficacy data and patient adoption will support the initial trial data. By directly targeting the source of emotional dysregulation, this new approach may offer hope for individuals suffering from PTSD, providing them with a personalized and effective treatment option. Moreover, its nonpharmacological nature and ability to be used alongside existing therapies make Prism a potential new option in the management of PTSD.

I have no relationship or conflict of interest with this company or product.