A Houston-based company is taking a medicine-free approach to target brain neurologically associated with mental illness.

Nexalin Technology’s patented, FDA-cleared frequency-based waveform targets key centers of the midbrain to support the normalization of neurochemicals through a process known as Transcranial Alternating Current Stimulation (tACS). Delivered via a non-invasive device, the treatment gently stimulates the hypothalamus and midbrain, helping to “reset networks associated with symptoms” of anxiety and insomnia. Early clinical evidence suggests this approach can promote healthier brain function and improved sleep.

Through its recently appointed scientific advisory board (SAB), Nexalin also aims to target Alzheimer’s disease with a clinical development pipeline supported by published data and internal data from studies involving its proprietary DIFS technology. Nexalin’s Gen-2 SYNC and Gen-3 Halo headset delivers the DIFS, which is a waveform that can penetrate deep brain structures implicated in cognitive decline and mental illness.

The board includes experts in neurology, neuroimaging and neurodegenerative diseases with Dr. Mingxiong Huang, Dr. David Owens, and Dr. Abe Scheer coming on board. Nexalin plans to initiate new Alzheimer’s-focused clinical studies in the Q3 2025 by incorporating cognitive testing, imaging biomarkers, and guided metrics to assess treatment efficacy and neural activation.

“I am excited to work alongside Nexalin’s leadership and fellow SAB members to help guide the next generation of non-invasive neuromodulation therapies,” Huang said in a news release. “The intersection of neuroimaging, brain stimulation, and clinical science holds enormous potential for treating neurodegenerative disease.”

Recently, Nexalin’s proprietary neurostimulation device moved forward with a clinical trial that evaluated its treatment of anxiety disorders and chronic insomnia in Brazil. The first of Nexalin’s Gen-2 15-milliamp neurostimulation devices was 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. The Nexalin Gen-2 15-milliamp neurostimulation device has also been approved in China, Brazil and Oman. Its Gen 1 device first received FDA clearance in 2003, according to the company's website.

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.