Nexalin Technology announces ‘positive’ study data in MDD

Nexalin Technology announced positive results of a clinical study designed to evaluate the feasibility, safety, and efficacy of transcranial alternating current dynamic frequency stimulation as an add-on treatment for the symptoms of major depressive disorder, MDD, also known as clinical depression, a mental health condition that affects mood, behavior, appetite, and sleep. The study was designed as a 4-week, double-blind, randomized, sham-controlled trial, in which sixty-six participants were recruited and randomly assigned to receive 20 40-minute sessions of either active treatment using the Company’s non-invasive Deep Intracranial Frequency Stimulation technology or sham stimulation. Significant differences were found in the reductions in the Hamilton Depression Rating Scale scores at week 4. Response rates at week 4 were significantly higher in the active tACS group than in the sham tACS group. In the active tACS group, a correlation between the mean change in alpha power and HAMD-17 scores at week 4 was found, and the mean change in alpha power was significantly greater for responders. No serious adverse events were observed in this trial.