Nexalin reports results of study of Gen-2 15 mA neurostimulation device

Nexalin Technology reported the results of a study in patients with treatment-resistant depression concerning the potential therapeutic benefits of its second-generation, 15 milliamp neurostimulation device, which indicated a substantial and statistically significant benefit in patients. The clinical trial was funded by the Company’s joint venture partner, Wider Come Limited, and its related companies, and was conducted at the Xuanwu Hospital, Capital Medical University in Beijing, China. The results were also published in General Psychiatry, an open-source, peer-reviewed scientific journal. The published results of the study concluded that repeated treatment with Nexalin’s neurostimulation device suggests an acute effect in reducing depressive symptoms in patients with TRD. In addition, no adverse events were observed during treatment. As part of the clinical study, 7 migraine patients were treated at the Xuanwu Hospital. Treatment was administered for 4 consecutive weeks via the forehead and both mastoid. Efficacy and adverse reactions were assessed at a 2-week screening/baseline period followed by a 4-week treatment phase. The study concluded that twice daily 15mA tACS, a unique form of non-invasive brain stimulation, offers an acute effective intervention for patients with TRD. The study showed that all patients with TRD had a significant reduction in depression symptoms after the 4-week treatment, and all of them achieved a clinical response. The previous 8-week randomized, double-blind, sham-controlled trial evaluating 100 patients with major depressive disorder (MDD), published in the international journal, Brain, indicated that patients receiving treatment with the Company’s Gen-2, 15mA neurostimulation device had better remission and response rates than the sham group. Compared with sham treatment, almost all depressive symptoms among the active treatment showed significant improvement. Moreover, there was no significant statistical difference in adverse events between the two groups.