HOUSTON, Texas—Approximately 17.5 veterans die by suicide every day in the United States, and 7% of veterans are diagnosed each year with post-traumatic stress disorder (PTSD). Against that backdrop, Texas A&M Health researchers are helping to advance a more personalized approach to treating the disorder.
New technology developed by Wave Neuroscience, a California-based company, in collaboration with the research team of Kenneth S. Ramos, MD, PhD, with the Texas A&M Health Institute of Biosciences and Technology, has recently received FDA clearance for a system that maps and treats the specific parts of the brain impacted by PTSD. While the results are being processed for public dissemination, the findings have demonstrated promising results to revolutionize PTSD treatment options.
PTSD is a mental health condition that can develop after exposure to an event beyond average stressors, like combat, accidents, natural disasters or other forms of violence. About 6% of people will develop PTSD symptoms in their lifetimes, with women and veterans experiencing much higher rates.
Since PTSD became an official diagnosis in 1980, the most common treatments have been talk therapy and serotonin reuptake inhibitor (SSRI) medications, such as sertraline and fluoxetine. But statistics show that those treatments don’t work for everyone.
A 2020 study reviewing medications for PTSD found that while some patients improved, many did not. Patients’ self-reported symptoms improved by 6.8 to 10.1 points, and only up to 10.9% achieved remission.
The Wave Neuroscience clinical trial revealed much more promising preliminary results, according to the company’s 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.”
Making it personal
The treatment uses Magnetic e-Resonance Therapy (MeRT), a technology created by Wave Neuroscience that combines an electroencephalogram (EEG) with transcranial magnetic stimulation. The EEG records electrical activity of the brain, while TMS—which is already used to treat other mental health conditions—uses magnetic pulses through a coil placed on 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 personalization is at the heart of MeRT.
Ramos, a physician-scientist with decades of experience in precision medicine, focuses on treatment tailored to the specific person and ailment rather than a “one-size-fits-all” approach.
“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.”
As a leading researcher in precision medicine, Ramos was the obvious choice for Wave Neuroscience to bring into their study, said Fred Walke, chief executive officer at the company.
TMS is typically done generically, Ramos explained, but MeRT takes it one step further by customizing it to the person being treated.
Each of us is 99.9% the same, but the 0.1% difference among us dramatically changes the picture. By tailoring the treatment to the individual, the researchers were able to work with that person’s brain specifically and demonstrate significant decreases in severity of PTSD symptoms.
Ramos compared the two treatments to fixing a leaky roof: TMS, he said, is like putting a tarp over the leak to address the symptoms, while MeRT is more targeted, akin to replacing the broken shingles and addressing the problem at its source.
Breaking the mold
The path to FDA clearance began in 2024, when MeRT received the FDA breakthrough design designation, said Rick Silva, PhD, executive director of clinical trials at the Institute of Biosciences and Technology.
This designation provides an expedited pathway for FDA review. Strict scientific and medical guidelines still must be met, but the designation can reduce some of the administrative tasks that can delay getting treatments to patients.
Reaching the final stages of FDA clearance is a time-consuming and rigorous task, but for those involved, it’s all worth it.
This project, Silva said, was especially gratifying because it began during the COVID-19 pandemic and moved very quickly for an FDA clearance. While medical device clinical trials typically take around a decade to complete and gain FDA clearance, this was done in just over two years, he said.
The rigor it takes to succeed in this space reflects the expertise and talent of the Wave Neuroscience team, and it could not have been done without them, he added.
“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.”
For Israel Liberzon, MD, distinguished professor in psychiatry and behavioral sciences at the Texas A&M Naresh K. Vashisht College of Medicine, the clearance represents an important addition to the PTSD treatment landscape.
Liberzon served as the lead psychiatrist and PTSD expert for the study. He said once this treatment gets to patients, it will be the only non-medication treatment option for PTSD cleared by the FDA.
“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.”
The MeRT clinical trial involved five sessions per week over five to six weeks. The beneficial effects appear to be long-lasting beyond the termination of treatment.
“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.”
The technology could eventually have applications beyond PTSD, Won said, including depression, anxiety and other conditions.
Hope on the horizon
For Leslie S. Prichep, PhD, chief scientific officer of Wave Neuroscience, the clearance signals a new era for mental healthcare.
“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 this alternative provides hope to those struggling with PTSD and their loved ones. He also hopes the more individualized approach will help reduce the stigma around mental health, as treatment becomes like putting a cast on a broken bone.
“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.”
Alongside Texas A&M Health, Wave Neuroscience is working with key stakeholders to broaden access to the treatment and ensure it is affordable for patients 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 team brings together decades of expertise spanning disciplines and technology, all with the goal of reducing suffering for people living with PTSD. FDA clearance brings them one step closer to that goal.
“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.”
By LASHA MARKHAM for VITAL RECORD
