FDA Clears First Nonmedication PTSD Treatment Using Personalized Brain Stimulation

The FDA has cleared a system that uses a patient's own brain activity data to personalize magnetic stimulation for post-traumatic stress disorder (PTSD), adding the first nonmedication treatment option cleared for the condition. The technology was developed by California-based Wave Neuroscience in collaboration with a research team led by Dr. Kenneth S. Ramos at the Texas A&M Health Institute of Biosciences and Technology.

About 6% of people develop PTSD symptoms during their lifetime, with substantially higher rates among women and veterans. In the United States, roughly 17.5 veterans die by suicide every day, and 7% of veterans are diagnosed with PTSD each year. Since PTSD became an official diagnosis in 1980, standard treatments have included talk therapy and SSRI medications such as sertraline and fluoxetine, which do not work for everyone.

The new treatment, called Magnetic e-Resonance Therapy (MeRT), combines an electroencephalogram (EEG), which measures electrical activity in the brain, with transcranial magnetic stimulation (TMS), which delivers magnetic pulses through a coil placed against the scalp. TMS was previously FDA-cleared only for treatment-resistant depression; adding an AI-derived algorithm let researchers personalize the protocol for each patient's brain activity rather than using the same standardized pattern for everyone.

Wave Neuroscience's chief medical officer, Erik Won, said the company's FDA trial reported a 52% reduction in PTSD symptoms and 68% remission, compared with a 2020 review of PTSD medications in which self-reported symptom scores improved by 6.8 to 10.1 points and remission reached no more than 10.9%. The clinical findings are still being prepared for public dissemination, and the figures reported so far are preliminary results from the company.

MeRT received an FDA breakthrough device designation in 2024, which can accelerate review by reducing administrative delays while still requiring the technology to meet scientific and medical standards. According to Dr. Rick Silva, executive director of clinical trials at the Institute of Biosciences and Technology, medical device trials often take about a decade to reach clearance, but this one took just over two years.