Houston healthtech leader launches clinical trial for innovative anxiety-treating device
making waves
Houston-based Nexalin Technology’s proprietary neurostimulation device will move forward with a new clinical trial evaluating its treatment of anxiety disorders and chronic insomnia in Brazil.
The first of Nexalin’s Gen-2 15-milliamp neurostimulation devices have been shipped to São Paulo, Brazil, and the study will be conducted at the Instituto de Psiquiatria university hospital (IPq-HCFMUSP). The shipments aim to support the launch of a Phase II clinical trial in adult patients suffering from anxiety and insomnia, according to a news release.
“Brazil is an important emerging market for mental health innovation, and this collaboration marks our first IRB-approved study in the region,” Mike White, CEO of Nexalin, said in the release.
The study will be led by Dr. Andre Russowsky Brunoni, who specializes in neuromodulation and interventional psychiatry. He currently serves as director of the interventional psychiatry division at IPq-HCFMUSP and this summer will join UT Southwestern in Dallas and its Peter O’Donnell Jr. Brain Institute as a professor of psychiatry.
The Phase II study plans to enroll 30 adults in São Paulo and assess the efficacy of Nexalin’s non-invasive deep intracranial frequency stimulation (DIFS™) of the brain in reducing anxiety symptoms and improving sleep quality, according to the company. Using the Hamilton Anxiety Rating Scale (HAM-A), the trial’s goal is a reduction in anxiety symptoms, and assessments of sleep onset latency, total sleep time, overall sleep quality, depressive symptoms and clinical impression of improvement. The company plans to share results in a peer-reviewed scientific journal.
“Anxiety and insomnia are very common conditions that often occur together and cause significant distress,” Brunoni added in the news release. “In this study, we are testing a new, non-invasive brain stimulation technology that has shown promising results in recent research. Our goal is to offer a safe, painless, and accessible alternative to improve people’s well being and sleep quality.”
The Nexalin Gen-2 15-milliamp neurostimulation device has been approved in China, Brazil, and Oman.
The company also enrolled the first patients in its clinical trial at the University of California, San Diego, in collaboration with the VA San Diego Healthcare System for its Nexalin HALO, which looks to treat mild traumatic brain injury and post-traumatic stress disorder in military personnel and the civilian population. It also recently raised $5 million through a public stock offering. Read more here.
