Nexalin Technology announces results of clinical study on Gen-2 tACS device

Nexalin Technology 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. 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 San Diego Healthcare System, and the Radiology, Psychiatry and Neurosciences Departments of UC San Deigo. 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 “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. A repeated analysis of variance measurement tested the treatment effect in resting-state magnetoencephalography data. Post-concussive symptoms were assessed using the Rivermead Post-Concussion Symptoms Questionnaire, Neurobehavioral Symptom Inventory, and McGill Pain Questionnaire. When measured by the MPQ pain scale, the Nexalin treatment group showed a significant reduction in pain when compared to the sham group, as measured by MPQ. Additionally, the active treatment group showed reduced RPQ and NSI symptoms relative to the sham group. Additionally, no adverse events were observed during treatment in the two groups. As part of the study, MEG was used to visually assess neuronal changes in veterans with combat-related mTBI after they received treatment with Nexalin’s non-invasive, frequency based deep brain stimulation. Before and after MEG imaging demonstrated significant changes 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.