- Nexalin Technology (NXL, Financial) receives IRB approval in Brazil for Phase II trial targeting anxiety and insomnia.
- The study will evaluate the Gen-2 neurostimulation device at one of Latin America's leading psychiatric research institutions.
- Led by Dr. Andre Russowsky Brunoni, the trial aims to enroll 30 adult patients in SĂŁo Paulo.
Nexalin Technology, Inc. (NXL), a leader in neurostimulation technology, has announced that it has received institutional review board (IRB) approval in Brazil to commence a Phase II clinical trial. This key milestone represents the company's first regulatory approval in Latin America and expands its international clinical trials footprint. The trial will assess the efficacy of Nexalin's Gen-2 neurostimulation device in treating anxiety disorders and chronic insomnia.
The study is set to be conducted at the Instituto de Psiquiatria do Hospital das ClĂnicas da Faculdade de Medicina da Universidade de SĂŁo Paulo (IPq-HCFMUSP), recognized as one of the most prestigious psychiatric research institutions in Latin America. The trial, led by Dr. Andre Russowsky Brunoni, will enroll 30 adult patients suffering from anxiety and insomnia—conditions that commonly occur together and significantly impact quality of life.
The primary endpoint of the study is to measure the reduction in anxiety symptoms using the Hamilton Anxiety Rating Scale (HAM-A) at baseline and after treatment, including a follow-up after four weeks. Secondary endpoints encompass assessments of depressive symptoms, sleep onset latency, total sleep time, overall sleep quality, and clinical improvement. The first Gen-2 device has already been shipped to SĂŁo Paulo, with additional units and disposable electrodes to follow shortly.
Nexalin's CEO, Mark White, expressed excitement about the collaboration with IPq-HCFMUSP and highlighted the strategic significance of the trial in advancing Nexalin's global regulatory and clinical strategy. "Brazil is an important emerging market for mental health innovation, and this collaboration marks our first IRB-approved study in the region," White noted.
The results of the trial are anticipated to be published in a peer-reviewed scientific journal, further validating Nexalin's pursuit of non-invasive treatments for mental health conditions using advanced neurostimulation technology.
