FDA okays Israel-developed brain modulation device to treat PTSD

There are a variety of treatments for post-traumatic stress disorder, but none have previously allowed patients to use non-invasive technology to self-regulate their brain activity.

That changed on March 21, when Israeli company GrayMatters Health (GMH), developer of digital self-neuromodulation therapies for mental disorders, announced that it has received clearance from the US Food and Drug Administration to market its flagship product, Prism, for post-traumatic stress disorder, better known as PTSD.

Prism is a two-part device. It consists of a cap fitted with special electrodes worn by the patient. At the same time, the person engages with a unique interactive audio-visual interface that is meant to help them modulate their brain activity through a positive feedback loop.

The system focuses on helping patients control the activity of their amygdala, the small region of the brain primarily associated with the limbic system, which mediates emotion and memory. The amygdala is a paired structure, with one part on each side of the brain.

“When a patient is successful in lowering the activity of the amygdala, or the amygdala-related signal, then they get positive feedback from the device,” Prof. Talma Hendler, developer of the technology, told The Times of Israel.

Hendler, professor of neuroscience and psychiatry at Tel Aviv University and director of the Sagol Brain Institute at the Tel Aviv Sourasky Medical Center, added that when a patient does this repeatedly, they learn the mental strategy that moves their emotional system to a calmer state.

Hendler said she expects Prism to be commercially available for doctors to prescribe starting next year. It will be sold only to outpatient and private clinics, where staff will be trained in its use and patients will be able to undergo 15 half-hour sessions with the device.

While wearing the cap, the patient watches a busy hospital or clinic waiting room on the screen. Animated figures are standing, walking around, and yelling. Babies are crying. Someone tries to get the attention of the clinic administrator behind the counter, growing increasingly agitated.

“When the patient is successful in regulating their limbic system, then the room relaxes, as well. Figures start to sit down and the noises are lowered. So it is kind of resonant with the patient’s brain. This is the positive feedback. It’s continuous, and the more you go below your baseline, the quieter the waiting room gets,” Hendler explained.

PTSD is most closely associated with soldiers and war, but anyone who has experienced a traumatic event is liable to suffer from the disorder.

A 2019 study estimated the number of adult survivors of war suffering PTSD or major depression worldwide at over 350 million. In the US, approximately one in 20 people develop PTSD in any given year, according to the Department of Veteran Affairs.

In Israel, as of December 2020, some 5,000 people were recognized by the Defense Ministry as suffering from PTSD, a number that is likely far lower than the actual number of veterans with the condition.

Prism was developed using research done with IDF soldiers who underwent functional MRI (fMRI) scans before and after combat situations in 2009.

“We found that the soldiers who had more amygdala activity prior to going into action developed more PTSD symptoms. This was the initial hint that amygdala hyper-activation is a marker for possibility developing psychopathology following trauma,” Hendler said.

However, working with fMRIs was too expensive and not scalable, so the focus shifted to the electroencephalogram (EEG). By putting subjects into fMRI scanners wearing specialized EEG caps, researchers could fuse the data from both using advanced statistical models. This created the EEG-fMRI-Pattern (EFP) biomarkers used in Prism.

Prism is intended as an adjunct treatment for PTSD and can be used in conjunction with psychotherapy, psychiatric medications, EMDR, medical marijuana, and other interventions.

“The more options the better,” said Prof. Rachel Dekel, who specializes in trauma and PTSD.

Dekel, of the Louis and Gabi Weisfeld School of Social Work at Bar-Ilan University, was not involved in Prism’s research and development.

She told The Times of Israel that PTSD treatment needs to be tailored to the individual. Some interventions are not suitable for certain individuals, and psychotherapy and prolonged exposure therapy may be too overwhelming for some.

“They don’t want to be re-exposed to the trauma. This leads to patients to drop out of treatment,” Dekel said.

She suggested that Prism’s audio-visual aspect is a boon for professionals treating young PTSD sufferers.

“Young people love working with computers, virtual reality, and the like,” she said.

GMH’s partners in developing and bringing Prism to FDA approval and market include Otsuka Medical Devices Co., Ltd., McLean Harvard Medical School Affiliate, Tel Aviv Sourasky Medical Center, and Sheba Tel Hashomer City of Health.