FDA Clears First-of-Its-Kind Nonmedication Treatment for PTSD

The FDA has cleared a system that uses brain activity data to personalize magnetic stimulation for PTSD, adding a new nonmedication treatment option.

Every day in the United States, approximately 17.5 veterans die by suicide, while 7% of veterans are diagnosed each year with post-traumatic stress disorder (PTSD). Against this backdrop, researchers at Texas A&M Health are helping advance a more personalized approach to treating PTSD.

A system developed by California-based Wave Neuroscience in collaboration with the research team of Dr. Kenneth S. Ramos at the Texas A&M Health Institute of Biosciences and Technology recently received FDA clearance. The technology maps brain activity associated with PTSD and uses those measurements to personalize treatment. The clinical findings are still being prepared for public dissemination, but preliminary results reported by the company suggest substantial improvements in PTSD symptoms.

PTSD can develop after exposure to events that go beyond ordinary stress, including combat, accidents, natural disasters, or other forms of violence. About 6% of people develop PTSD symptoms during their lifetimes, with substantially higher rates among women and veterans.

Since PTSD became an official diagnosis in 1980, common treatments have included talk therapy and selective serotonin reuptake inhibitor (SSRI) medications, such as sertraline and fluoxetine. These approaches, however, do not work for everyone.

A 2020 review of PTSD medications found that although some patients improved, many did not. Self-reported symptom scores improved by 6.8 to 10.1 points, while remission rates reached no more than 10.9%.

Personalized brain stimulation showed stronger trial results

Wave Neuroscience reported substantially stronger preliminary outcomes from its clinical trial, according to chief medical officer Erik Won, DO.

“In comparison to that study, our FDA trial reported a 52% reduction in symptoms, so more than a four-fold increase in efficacy,” Won said. “And more importantly, we saw 68% remission in our clinical trial. So, it’s really a quantum change, an inflection point in what we can offer to patients. From a clinical care perspective, that’s really meaningful.”

The treatment, called Magnetic e-Resonance Therapy (MeRT), combines an electroencephalogram (EEG), which measures electrical activity in the brain, with transcranial magnetic stimulation. TMS, already used for other mental health conditions, delivers magnetic pulses through a coil placed against the scalp.

“Transcranial magnetic stimulation, or TMS, was previously FDA-cleared for treatment-resistant depression,” Won said. “By adding an augmented AI-derived multivariate algorithm, we were able to personalize protocols that received FDA clearance for post-traumatic stress disorder, which should open up market access to about 13 million people who may be struggling with PTSD.”

That individualized targeting is central to MeRT.

Treatment is tailored to each brain

Ramos, a physician scientist with decades of experience in precision medicine, studies treatments designed around the characteristics of an individual patient and condition rather than using the same approach for everyone.

“Most clinical interventions for the treatment of PTSD do not work very well,” Ramos said. “So, this is a huge area where identifying interventions that could hopefully add quality of life to the people impacted by this disorder would be tremendously impactful.”

Fred Walke, chief executive officer of Wave Neuroscience, said Ramos’s expertise in precision medicine made him a natural collaborator for the study.

Traditional TMS generally uses a more standardized protocol, Ramos explained, whereas MeRT adjusts treatment according to the individual brain.

Humans are about 99.9% genetically alike, but the remaining 0.1% can have important effects. By personalizing treatment to each participant, the researchers were able to target individual brain activity patterns and observed significant reductions in PTSD symptom severity.

Ramos compared the difference to repairing a leaking roof. Standard TMS, he said, resembles placing a tarp over the leak to manage the symptoms, while MeRT is intended to be more targeted, like replacing damaged shingles and addressing the source of the problem.

FDA clearance followed an accelerated path

MeRT’s path toward FDA clearance began in 2024, when it received an FDA breakthrough design designation, according to Dr. Rick Silva, executive director of clinical trials at the Institute of Biosciences and Technology.

The designation can accelerate FDA review by reducing some administrative delays while still requiring the technology to meet scientific and medical standards.

Completing the final stages of FDA review remains a lengthy and demanding process.

Silva said this project was particularly rewarding because it began during the COVID-19 pandemic and reached FDA clearance unusually quickly. Medical device clinical trials often take about a decade to complete and secure clearance, he said, whereas this process took just over two years.

He credited the Wave Neuroscience team with the expertise needed to meet the scientific and regulatory demands of the project.

“I’ve been involved in probably close to 1,000 projects in academic medical centers over the years at varying degrees of depth and detail,” Silva said. “Patients are why I do what I do. It’s hard, and the failure rate is high, and it’s a lot of work. But when you get to a point where something is going to benefit patients, it’s very professionally gratifying and personally gratifying in many ways as well.”

PTSD gains a nonmedication treatment option

For Dr. Israel Liberzon, distinguished professor in psychiatry and behavioral sciences at the Texas A&M Naresh K. Vashisht College of Medicine, the clearance adds a different kind of option to PTSD care.

Liberzon, who served as the study’s lead psychiatrist and PTSD expert, said that once available to patients, MeRT will be the only FDA-cleared nonmedication treatment option specifically for PTSD.

“Right now, the FDA has approved only two medications for PTSD,” Liberzon said. “It doesn’t mean that only two of them are used, but both are SSRIs. This is the first time that in addition to the medication, we have a non-medication option. There is psychotherapy that people use for PTSD, but psychotherapies require a lot of effort. People must participate actively, and many drop out because it’s too anxiety-provoking. So now we have a unique alternative.”

Participants in the MeRT clinical trial received five sessions each week for five to six weeks. The beneficial effects appeared to continue after treatment ended.

“People living with PTSD have been left with trial-and-error treatment, medications and their side effects, and limited outcomes—even when treated by the most dedicated and experienced physicians,” Won said. “Wave’s FDA clearance signals a fundamentally different future: one in which PTSD can be objectively evaluated, precisely treated and meaningfully healed.”

Won said the technology could eventually be explored for other conditions, including depression and anxiety.

Dr. Leslie S. Prichep, chief scientific officer of Wave Neuroscience, said the clearance builds on decades of research into electrical brain activity and personalized intervention.

“The FDA clearance of the MeRT System reflects decades of scientific research using electrophysiological biomarkers in identifying abnormal brain activity profiles and guiding personalized intervention strategies,” Prichep said. “We believe this represents an important advancement toward a more objective, data-informed model of mental healthcare.”

Walke said he hopes a more individualized and objectively guided approach can also reduce stigma surrounding mental health treatment by making it resemble treatment for other physical conditions.

“One of the goals of the company is to create a platform for mental healthcare that uses objective imagery to help patients understand why they’re experiencing life the way that they are,” Walke said. “That insight, compounded with proven technologies, promises incredibly high efficacy when personalized.”

Wave Neuroscience and Texas A&M Health are also working with stakeholders to expand access and make treatment affordable through insurance coverage.

“Our hope is that this research and technology can be a catalyst for more widespread development and innovation of more effective, personalized and precision-guided treatments,” Won said. “This is proof positive that population-scale personalized medicine is not just an aspirational goal but is an achievable reality today.”

The MeRT effort brings together researchers and clinicians across several disciplines with the goal of reducing the burden of PTSD. FDA clearance moves the technology closer to broader patient use.

“Texas A&M has a very rich history of military and veteran priorities,” Ramos said. “It’s a no-brainer that Texas A&M faculty would be interested in and supportive of an initiative that hopefully would bring positive solutions to a big problem. And anything we could do to help alleviate that problem is going to go a long way towards making a difference in the individual’s life as well as the people who are close to them. I feel very fortunate that we at Texas A&M were meaningfully involved in this project.”