Nexalin Technology Announces Positive Results of Clinical Study Validating its Gen-2 tACS Device for Reducing Pain Among Veterans with Mild Traumatic Brain Injury at University of California, San Diego - Seite 2

A repeated analysis of variance (ANOVA) measurement tested the treatment effect in resting-state magnetoencephalography (MEG) data. Post-concussive symptoms (PCS) were assessed using the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), Neurobehavioral Symptom Inventory (NSI), and McGill Pain Questionnaire (MPQ). 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 (measured by total score) 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 (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.

Mark White, CEO of Nexalin Technology, stated, "We are encouraged by the results of the clinical study, reinforcing the significant reduction in pain and other persistent symptoms of mild traumatic brain injury among veteran patients. We look forward to further discussing the data at BARDA’s prestigious upcoming event. Importantly, this latest study builds on prior data in combat-related mTBI disclosed at the 2023 Military Health System Research Symposium (MHSRS) and validates the growing body of clinical evidence supporting Nexalin's new advanced 15 milliamp waveform. We believe the data we have reported provides evidence of the potential clinical efficacy of our neurostimulation device on improving mental healthcare outcomes among patients affected with mTBI, without any significant adverse effects. This is especially noteworthy given the growing number of patients seeking non-pharmacological treatment options. Additionally, it is further gratifying to learn from the results of our MEG studies that Nexalin therapy truly is a non-invasive deep brain stimulating tool, which can result in lasting therapeutic neuroplastic changes in brain disorders. We look forward to advancing the technology within the military and government agencies to bring hope to countless numbers of military and civilian patients impacted by these often-debilitating conditions in the United States and around the world.”