Summary: Nexalin’s Gen-2 neurostimulation device has received IRB approval in Brazil for a phase II clinical trial to evaluate its effectiveness in treating anxiety disorders and chronic insomnia.
Key Takeaways:
- Brazil is seen as a key emerging market for mental health innovation, according to Nexalin.
- The phase II trial of 30 adult patients will be conducted at the Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo.
- The primary endpoint is a reduction in anxiety symptoms measured by the Hamilton Anxiety Rating Scale; secondary endpoints include sleep quality and depressive symptoms.
Nexalin Technology Inc’s Gen-2 neurostimulation device has received institutional review board (IRB) approval in Brazil for a new clinical trial evaluating its use in the treatment of anxiety disorders and chronic insomnia.
The study will be conducted at the Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IPq-HCFMUSP).
The first Nexalin device has been shipped to São Paulo, Brazil, with additional units and single-use disposable electrodes scheduled for delivery. These shipments support the launch of a phase II clinical trial in adult patients suffering from anxiety and insomnia—two conditions that are frequently comorbid and significantly affect quality of life.
“We are excited to partner with IPq-HCFMUSP on this landmark study,” says Mark White, CEO of Nexalin, in a release. “This is a key milestone in our international strategy, as we expand the clinical evaluation of our second-generation neurostimulation technology. Brazil is an important emerging market for mental health innovation, and this collaboration marks our first IRB-approved study in the region.”
The phase II study will enroll 30 adults in São Paulo and assess the efficacy of Nexalin’s noninvasive brain stimulation in reducing anxiety symptoms and improving sleep quality. The trial’s primary endpoint is a reduction in anxiety symptoms, as measured by the Hamilton Anxiety Rating Scale at baseline, after treatment, and at a four-week follow-up. Secondary endpoints include assessments of depressive symptoms, sleep onset latency, total sleep time, overall sleep quality, and clinical impression of improvement.
“This trial is the first in Brazil to use Nexalin’s Gen-2, 15 mA device,” White says. “We view this as a strong validation of our global regulatory and clinical strategy as we continue to explore broader applications for our non-invasive technology.”
The study is led by Andre Russowsky Brunoni, MD, PhD, MBA, the director of the Interventional Psychiatry Division at IPq-HCFMUSP. He will join UT Southwestern in June 2025 as professor of Psychiatry and of the Peter O’Donnell Jr. Brain Institute.
Brunoni says in a release, “Anxiety and insomnia are very common conditions that often occur together and cause significant distress. In this study, we are testing a new, noninvasive 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.”
Results from the study are expected to be published in a peer-reviewed scientific journal.
