Nexalin Technology Announces Positive Clinical Study Data in Major Depressive Disorder

Nexalin Technology, Inc. recently 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 significant, and the combination of tACS with antidepressants is a feasible and effective approach for the treatment of MDD.”

Dr. David Owens, Chief Medical Officer of Nexalin, said “We are proud to announce these positive results and are honored to have the results published in such a prominent, peer-reviewed journal. While we have previously demonstrated powerful treatment effects from our DIFS technology alone, this was the first study in which we evaluated our technology in combination with an SSRI, which has become the gold standard treatment in the U.S. Most notably, we believe that this study demonstrated strong and statistically significant separation between the active group receiving treatment with DIFS and medication, versus the placebo groups receiving medication alone—exactly the results we were hoping to demonstrate in the trial. In fact, only one-third of the treated patients receiving medication alone showed improvement, whereas two-thirds receiving the combination showed improvement. Also noteworthy was the fact that no significant adverse effects were reported.”

Mark White, CEO of Nexalin, added “We believe this data strongly reinforces the growing body of clinical evidence supporting the potential of Nexalin’s new advanced 15 mAmp waveform to help combat the ongoing global mental health epidemic—both as a standalone drug-free treatment alternative, or in combination with existing pharmacological therapies. According to a 2022 National Survey on Drug Use and Health, an estimated 22.47 million adults, or 8.8% of all US adults in the United States, had at least one major depressive episode. Moreover, according to Future Market Insights, the MDD treatment market is forecast to reach US$ 14.96 billion by 2032 from US$ 11.51 billion in 2022. We believe the data provides further evidence of the significant impact of our non-invasive drug-free device on improving mental healthcare outcomes among patients affected with MDD. We look forward to advancing our technology in order to bring our new, effective therapies to the millions of patients suffering from mental health issues in the United States and around the world.”

Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin’s products are believed to be non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, and Oman. For more information, visit https://nexalin.com/.