Nexalin Technology, Inc. announced the positive results of a clinical study evaluating Nexalin's Gen-2 tACS device for reducing pain in veteran patients with Mild Traumatic Brain Injury (mTBI). The study was conducted at The University of California, San Diego, and is further detailed in an abstract co-authored by the United States Department of Veterans Affairs (VA) San Diego Healthcare System, and the Radiology, Psychiatry and Neurosciences Departments of UC San Deigo. mTBI is a leading cause of sustained physical, cognitive, emotional, and behavioral deficits in veterans and the general public.

However, the underlying pathophysiology is not completely understood, and there are few effective treatments for post-concussive symptoms (PCS). In addition, PCS and post-traumatic stress disorder (PTSD) symptoms overlap considerably. According to Global Market Insights, the Traumatic Brain Injuries Assessment Market size was valued at approximately $3.3 billion in 2022 and is projected to reach over $7.2 billion in 2032.

The study was conducted as a randomized, double-blind, placebo-controlled clinical trial over an eight-week period, with two groups being examined: an active tACS group and a sham tACS group. As part of the clinical study, 24 veteran patients with mTBI received twelve sessions of active or sham tACS over a period of four consecutive weeks, followed by a four-week follow-up period. The abstract summarizing the findings of the study was submitted for a presentation at the Biomedical Advanced Research and Development Authority (BARDA) "State of the Technology Meeting: Neurotrauma Diagnosis, Monitoring, and Assessment" on March 12, 2024.

BARDA is a U.S. government agency under the Department of Health and Human Services focusing on the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. Before and after MEG imaging demonstrated significant changes (i.e., p<0.01) in deep brain structures related to abnormal hyperactive waveforms in the brain, including both delta and gamma waves at the center of increased abnormal activity in the brain. Compared with the sham group, veterans in the active treatment group showed significant reductions in delta-band activity and abnormal gamma-band activity.

These reductions in abnormal activity may indicate that a healing of the neurons is occurring and may be returning certain abnormal areas of brain function to normal, which then suggests an improvement in GABA-ergic inhibitory functions.