Texas A&M Health, Wave Neuroscience Announce Second Phase of PTSD Clinical Trial

Efficacy and safety of innovative Magnetic EEG-guided Resonance Therapy (MeRT) will be evaluated

BRYAN-COLLEGE STATION, Texas--(BUSINESS WIRE)--Texas A&M University Health Science Center (Texas A&M Health) and Wave Neuroscience announced the second phase of their post-traumatic stress disorder (PTSD) clinical trial today. This phase will investigate the safety and efficacy of Magnetic EEG-guided Resonance Therapy (MeRT) in a randomized clinical trial for post-traumatic stress disorder, with or without persistent post-concussion symptoms (PPCS) from traumatic brain injury (TBI).

MeRT is a personalized, non-invasive, and non-pharmacological investigative treatment using electromagnetic stimulation of the brain. Up to 175 participants will be enrolled at study sites in Dallas, Texas, and San Diego, California.

The clinical trial is being directed by Kenneth Ramos, MD, PhD, executive director of Texas A&M Health Institute of Biosciences and Technology. Ramos has a history of changing the landscape of medicine, biotechnology and health care by leading several translational, clinical research, and educational programs that integrate diverse approaches to elucidate genomic mechanisms of disease and develop novel therapies.

“The results of the initial trial suggested that MeRT therapy may be effective for the treatment of post-traumatic stress disorder,” Ramos said. “This second phase of the investigation has been designed to further evaluate the efficacy and safety of MeRT in a larger and more diverse group of patients. Our goal is to find ways to improve the quality of life for patients afflicted with this devastating condition.”

Likewise, Wave Neuroscience, an innovative company focused on brain health, is a pioneer in offering treatments that have shown promise in optimizing brain performance. The company has been able to help individuals living with not just PTSD, but also traumatic brain injuries, depression and substance abuse.

“We’re tremendously honored to be collaborating with Texas A&M Health and Dr. Ramos,” said Dr. Erik Won, MD, President and Chief Medical Officer at Wave Neuroscience. “This trial will build on the amazing work of our phase I collaboration with U.S. Special Operations Command, Uniformed Services University of the Health Sciences, and the Henry M Jackson Foundation while facilitating the incorporation of civilians and non-military subjects into our study population. Our goal is to provide the most academically rigorous and scientifically robust methodology to provide confirmatory data in support of our mission to help vulnerable populations struggling with PTSD and TBI.”

During this phase of the trial, active or simulated MeRT will be provided during daily visits to the study site over a five-week period. After the investigative five-week period is completed, participants may receive up to two weeks of daily active stimulation sessions. Additional data collection visits may be completed remotely.

The first phase of the trial involved 74 participants, located in Tampa, Florida, and San Diego, California. For the second phase, adults age 18-65 may be eligible to participate if they have experienced symptoms of PTSD for at least six months and meet other eligibility criteria. Enrollment is also open to participants who live with PTSD combined with persistent post-concussive symptoms resulting from traumatic brain injury. The study will begin enrollment during Fall 2021 and continue through Spring 2023, with the goal 174 participants completing the trial.

Additional information is available at: https://clinicaltrials.gov/ct2/show/NCT02268084

If you would like to enroll in this trial or know someone that would, please contact Linda Saenz, senior administrative coordinator at Texas A&M Health, at [e-mail].

Magnetic EEG-guided Resonance Therapy

Magnetic EEG-guided Resonance Therapy is a type of precision medicine developed by scientists at Wave Neuroscience. MeRT uses each person’s own unique brain patterns to provide personalized magnetic stimulation. MeRT is currently studied for several brain health disorders. Find out more at waveneuro.com.

About Wave Neuroscience

Wave Neuroscience develops technologies that personalize and facilitate Braincare™. Wave combines decades of medical research with targeted applications to create greater access to better healthcare. When it comes to brain health insight and treatment, no one can do what we do. Our proprietary approach provides deep understanding and personalized treatments that open new paths to wellness and recovery. At every step, we provide evidence-based, world-class healthcare rooted in the principles of physics. For more information, visit waveneuro.com.

About Texas A&M Health

Texas A&M University Health Science Center (Texas A&M Health) comprises five colleges (dentistry, medicine, nursing, pharmacy and public health) and several centers and institutes with a shared mission of advancing health care for all. We serve the state and beyond with campuses and locations in Bryan-College Station, Dallas, Temple, Houston, Round Rock, Kingsville, Corpus Christi and McAllen. Learn more at health.tamu.edu or follow @TAMUHealth on Twitter