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Nexalin Technology Announces Positive Clinical Study Data in Major Depressive Disorder and Publication of Clinical Trial Results in Leading Scientific Journal
Study demonstrates strong statistical separation between patients receiving Nexalin’s DIFS® technology in combination with escitalopram (Lexapro) vs sham
About this update from Nexalin Technology, Inc.
[{"type":"text","content":"Study demonstrates strong statistical separation between patients receiving Nexalin’s DIFS® technology in combination with escitalopram (Lexapro) vs sham group receiving escitalopram alone Two-thirds of patients receiving the combination therapy showed improvement compared to just one-third of patients receiving medication alone HOUSTON, June 26, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) today 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. The results of the study were published in Brain Stimulation, the premier peer-reviewed journal in the field of neuromodulation. The article, titled “Effect of add-on transcranial alternating current stimulation (tACS) in major depressive disorder: A randomized controlled trial,” concluded: “The additional antidepressant effect of tACS is signi...