Nexalin Technology Receives IRB Approval in Brazil and Begins Clinical Trial for Anxiety and Insomnia

Core Insights - Nexalin Technology, Inc. has received IRB approval in Brazil for a clinical trial of its Gen-2 neurostimulation device aimed at treating anxiety disorders and chronic insomnia [1][3] - The Phase II clinical trial will involve 30 adult participants and will assess the efficacy of the device in reducing anxiety symptoms and improving sleep quality [2][3] - The study is being conducted in collaboration with the prestigious Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo [1][3] Company Developments - The first Nexalin device has been shipped to São Paulo, with more units and disposable electrodes to follow, supporting the launch of the clinical trial [2] - The trial's primary endpoint is a reduction in anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAM-A), with secondary endpoints including assessments of depressive symptoms and sleep quality [3][4] - Dr. Andre Russowsky Brunoni, a recognized expert in neuromodulation, is leading the study, which is seen as a significant step in Nexalin's global strategy [4][5] Industry Context - Anxiety and insomnia are prevalent conditions that often occur together, significantly impacting quality of life, highlighting the need for innovative treatment options [5] - Nexalin's non-invasive neurostimulation technology aims to provide a safe and effective alternative for improving mental health, addressing the ongoing global mental health epidemic [6]