Nexalin Technology's innovative neurostimulation device HALO™ Clarity is set to undergo independent clinical evaluation at the University of California, San Diego (UCSD) following recent Institutional Review Board (IRB) approval. The study will focus on treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD), particularly in military personnel.
The milestone approval follows successful pilot testing at UCSD, prompting the university to request 50 HALO devices for their research initiative. While Nexalin will provide the devices, the company maintains an arms-length relationship with the study, neither sponsoring nor directing the research outcomes.
Advanced Technology Platform
The HALO™ Clarity device leverages Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology to deliver non-invasive brain stimulation without medications or surgical intervention. The system stands out for its patient-centric design, allowing for at-home treatment administration while maintaining professional oversight through remote monitoring capabilities.
Mark White, CEO of Nexalin Technology, emphasized the significance of the UCSD trial: "This approval underscores our commitment to delivering innovative, non-invasive solutions for mental health and neurological disorders. The independent study will provide essential data to further establish HALO as a revolutionary treatment option for military personnel and others suffering from mTBI and PTSD."
Virtual Clinic Innovation
Nexalin has developed a sophisticated virtual clinic model integrating artificial intelligence and proprietary Electronic Data Capture (EDC) technology. This digital infrastructure includes:
- Real-time data acquisition and analysis during clinical trials
- An interactive smartphone application for monitoring treatment adherence
- Telemedicine capabilities enabling direct patient-clinician communication
David Owens, CMO of Nexalin Technology, highlighted the potential impact: "The combination of DIFS technology with our virtual clinic model allows us to bring treatment into the homes of patients, ensuring accessibility, convenience, and enhanced patient outcomes."
Clinical Implementation
The virtual clinic framework is designed to manage the entire clinical trial process remotely, providing physicians with real-time digital data on patient progress. This approach aims to maximize accessibility while maintaining rigorous clinical oversight.
The HALO device's key advantages include:
- Drug-free treatment alternative
- Comfortable home-based administration
- Continuous remote monitoring capabilities
- Real-time treatment adjustments
While the HALO device shows promise, it remains under evaluation and has not yet received FDA approval for these specific applications in the United States. The upcoming UCSD trial represents a crucial step in validating the technology's safety and efficacy for treating neurological and mental health conditions.
