A new approach to treating post-traumatic stress disorder (PTSD) has received FDA clearance, providing a personalized alternative for people who have not found sufficient relief through existing treatments. Developed by California-based Wave Neuroscience in collaboration with researchers at the Texas A&M Health Institute of Biosciences and Technology, the technology uses measurements of brain activity to guide targeted magnetic stimulation.
The first results of clinical trials are encouraging. According to Wave Neuroscience, patients experienced a 52% reduction in PTSD symptoms, while 68% achieved remission. Full results are still being prepared for public release, but researchers believe the technology could significantly expand treatment options for millions of people.
The need for more effective PTSD care is considerable. In the United States, approximately 17.5 veterans commit suicide each day, and approximately 7% of veterans are diagnosed with PTSD each year.
PTSD can develop after traumatic experiences such as military combat, serious accidents, natural disasters, or violence. An estimated 6% of Americans will experience PTSD in their lifetime, with higher rates among women and veterans.
Why Current Treatments for PTSD Are Not Enough
Since PTSD was officially recognized as a diagnosis in 1980, treatment has largely focused on psychotherapy and medications called selective serotonin reuptake inhibitors (SSRIs), including sertraline and fluoxetine.
Although these approaches can help, many patients continue to experience symptoms despite treatment.
A 2020 review of PTSD medications found that patients reported improvements ranging from 6.8 to 10.1 points in symptom ratings. However, remission rates only reached 10.9% at most.
Wave Neuroscience reported significantly better preliminary results in its clinical trial. Erik Won, DO, the company’s chief medical officer, described the results as a major advance over previously reported drug results.
“Compared to this study, our FDA trial reported a 52% reduction in symptoms, more than four times greater effectiveness,” Won said. “And more importantly, we saw a 68% remission in our clinical trial. So it’s really a quantum shift, an inflection point in what we can offer patients. From a clinical care perspective, it’s really significant.”
These results are promising, although they come from different studies and should not be interpreted as a direct comparison of treatment effectiveness.
How Personalized Brain Stimulation Works
The newly authorized system uses magnetic electronic resonance therapy (MeRT), a technology that combines measurements of brain activity with targeted magnetic stimulation.
First, an electroencephalogram (EEG) records electrical signals from the brain. This information helps guide a personalized treatment plan using transcranial magnetic stimulation, or TMS.
During TMS, a coil positioned against the scalp delivers magnetic pulses that stimulate brain activity. The technique has already been used for other psychiatric disorders, including treatment-resistant depression.
What sets MeRT apart is its use of an AI-assisted algorithm to personalize stimulation protocols based on each patient’s brain activity rather than relying on a standardized approach.
“Transcranial magnetic stimulation, or TMS, had previously been approved by the FDA for treatment-resistant depression,” Won said. “By adding a multivariate algorithm derived from augmented AI, we were able to personalize protocols that received FDA clearance for post-traumatic stress disorder, which is expected to open market access to approximately 13 million people who may suffer from PTSD.”
Dr. Kenneth S. Ramos, a physician-scientist at Texas A&M Health with extensive experience in precision medicine, helped guide the research.
His work focuses on tailoring medical care to the characteristics of each patient rather than assuming that everyone will respond to the same treatment.
“Most clinical interventions for treating PTSD don’t work very well,” Ramos said. “So this is a broad area where identifying interventions that could hopefully improve the quality of life of people affected by this disorder would have a huge impact.” »
Fred Walke, CEO of Wave Neuroscience, said Ramos was a natural choice for the project because of his expertise in personalized medicine.
Targeting PTSD with Greater Precision
Conventional TMS generally follow less individualized treatment protocols. MeRT builds on the same underlying technology but adjusts the treatment based on the patient’s specific brain activity.
Ramos emphasized that even small biological differences between people can have major implications for medical care. Humans are about 99.9% genetically identical, but the remaining 0.1% contributes to differences that can influence how individuals respond to treatment.
By accounting for these differences and tailoring stimulation to each person’s brain, researchers observed substantial reductions in PTSD symptom severity.
Ramos illustrated the distinction with an analogy involving a leaky roof.
He compared conventional TMS to covering a leak with a tarp to manage its effects. MeRT, on the other hand, aims to provide a more targeted solution, comparable to identifying and replacing the damaged shingles causing the problem.
The broader goal is to move beyond treating patients with standardized protocols and toward interventions guided by measurable biological information.
From Breakthrough Designation to FDA Authorization
The regulatory process reached an important milestone in 2024, when MeRT received Breakthrough Device designation from the FDA.
Dr. Rick Silva, executive director of clinical trials at the Texas A&M Health Institute of Biosciences and Technology, explained that this designation helps promising technologies pass regulatory review more efficiently.
This does not eliminate scientific or medical requirements. Instead, it can streamline communication and reduce administrative delays while preserving the standards necessary for FDA clearance.
Silva said the progress was particularly significant because the project began during the COVID-19 pandemic and moved through the regulatory process at unusual speed.
According to Silva, the development of a medical device and its clinical evaluation can often take around 10 years before obtaining authorization. This project completed the corresponding process in just over two years.
He credited the experience and dedication of the Wave Neuroscience team with helping make this accelerated progress possible.
“I’ve probably been involved in close to 1,000 projects at academic medical centers over the years, to varying degrees of depth and detail,” Silva said. “Patients are the reason I do what I do. It’s difficult, the failure rate is high, and it takes a lot of work. But when you get to the point where something is going to benefit patients, it’s very rewarding professionally and personally in many ways as well.”
A new drug-free option for PTSD patients
Dr. Israel Liberzon, distinguished professor of psychiatry and behavioral sciences at Texas A&M Naresh K. Vashisht College of Medicine, served as the study’s lead psychiatrist and specialist in PTSD.
He believes this authorization represents a significant expansion of treatments available for PTSD.
According to Liberzon, MeRT will become the only non-drug treatment specifically approved by the FDA for PTSD once it reaches patients.
“Currently, the FDA has only approved two medications for PTSD,” Liberzon said. “That’s not to say that only two of them are used, but they are both SSRIs. This is the first time that in addition to medications, we have a non-drug option. There is psychotherapy that people use for PTSD, but psychotherapies require a lot of effort. People have to actively participate, and many drop out because it’s too anxiety-inducing. So now we have a unique alternative.”
In the clinical trial, participants received five treatment sessions each week over a period of five to six weeks.
The researchers reported that improvements appeared to persist after treatment sessions ended, suggesting that the benefits may extend beyond the active treatment period.
For patients dealing with medication side effects or having difficulty following psychotherapy, treatment based on personalized brain stimulation could be another option.
“People living with PTSD have been left with trial-and-error treatment, medications and their side effects, and limited results, even when treated by the most dedicated and experienced doctors,” Won said. “The FDA’s approval of Wave heralds a fundamentally different future: one in which PTSD can be objectively assessed, accurately treated, and meaningfully cured.”
Won also thinks the technology could eventually be adapted for other psychiatric disorders, including depression and anxiety.
Could personalized brain therapy transform mental health?
Dr. Leslie S. Prichep, chief scientific officer of Wave Neuroscience, sees FDA clearance as an important step toward treatment decisions guided by objective measures of brain function.
“The FDA’s clearance of the MeRT system reflects decades of scientific research using electrophysiological biomarkers to identify abnormal brain activity patterns and guide personalized intervention strategies,” Prichep said. “We believe this represents an important step forward toward a more objective, data-driven model of mental health care.” »
Walke believes that giving patients clearer information about their brain activity could also help change public attitudes toward mental illness.
He compared the idea to treating a fracture with a cast. By making mental health issues easier to understand through measurable physical information, the company hopes to reduce stigma and help patients better understand their experiences.
“One of the company’s goals…
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