Nexalin Technology, Inc. announced positive results of a clinical study designed to evaluate the feasibility, safety, and efficacy of transcranial alternating current dynamic frequency stimulation (tACS) 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 (DIFS®) technology (77.5Hz, 15 mA) or sham stimulation. The study involved the combined use of escitalopram (Lexapro), a selective serotonin reuptake inhibitor (SSRI), throughout the 4-week period.

Escitalopram is a commonly prescribed medication used to treat anxiety and major depressive disorder. Significant differences were found in the reductions in the Hamilton Depression Rating Scale (HAMD-17) scores at week 4 (t = 3.44, P = 0.001). Response rates at week 4 were significantly higher in the active tACS group than in the sham tACS group (22 out of 33 patients [66.7 %] versus 11 out of 33 [33.3 %], P = 0.007).

In the active tACS group, a correlation between the mean change in alpha power and HAMD-17 scores at week 4 was found (r = 2.38, P = 0.024), and the mean change in alpha power was significantly greater for responders (Z = 2.46, P = 0.014). No serious adverse events were observed in this trial.