FDA approves world-first brain modulation device to treat PTSD

The device has been tested on Israeli soldiers.
Loukia Papadopoulos
Prism helps patients control the activity of their amygdala.jpg
Prism helps patients control the activity of their amygdala.

onurdongel/iStock 

Israeli company GrayMatters Health (GMH), the company behind digital self-neuromodulation therapies for mental disorders, has announced that it has received clearance from the US Food and Drug Administration to market its healing product Prism for PTSD, conceived for treating post-traumatic stress disorder (PTSD).

This is according to an article by the Times of Israel published on Friday.

Prism for PTSD works in tandem with a cap that has special electrodes. This set-up helps to identify and implement mental strategies that lower their amygdala-derived-EFP biomarker. The amygdala is the area of the brain primarily responsible for the control of emotion and memory. 

“When a patient is successful in lowering the amygdala-derived signal, then they get positive feedback from the device,” Prof. Talma Hendler, professor of neuroscience and psychiatry at Tel Aviv University, director of the Sagol Brain Institute at the Tel Aviv Sourasky Medical Center and developer of the technology, told The Times of Israel.

Prism, she argued, teaches patients the mental strategy that moves their emotional system to a calmer state.

She now expects Prism to be commercially available for doctors to prescribe starting in 2023. However, it will not be made available everywhere focusing instead primarily on outpatient and private clinics where staff can be trained in its use and administration.

If used properly, it is extremely efficient.

“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 said.

More common amongst soldiers

According to the U.S. Department of Veteran affairs, about 5 out of every 100 adults (or 5 percent) in the U.S. has PTSD in any given year. In 2020, about 13 million Americans had PTSD. In addition, women are more likely to develop PTSD than men. About 8 of every 100 women (or 8 percent) and 4 of every 100 men (or 4 percent) will have PTSD at some point in their life. 

The most common sufferers of PTSD however are soldiers and Prism was developed using studies conducted on IDF soldiers who underwent functional MRI (fMRI) scans before and after combat 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 told the Times of Israel.

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