BCI and Hybrid BCI Wearable Agency Device for ALS.

About This Grant

PAR-24-246 Application 2002755 Project Summary Cognixion proposes a groundbreaking project focused on developing and validating the Cognixion Axon-R, a wearable augmented reality (AR) and brain-computer interface (BCI) device combined with Cognixion’s Assisted Reality generative AI application software. This system is designed to restore communication abilities for individuals with Amyotrophic Lateral Sclerosis (ALS) and related neurodegenerative conditions. As this disease progress, traditional communication tools, such as eye-tracking systems, become less effective, leaving patients isolated and unable to express their needs. The Cognixion solution addresses this critical gap by combining AR, BCI, and AI-supported speech generation to enable communication through neural signals, even when voluntary motor control is nonexistent. The proposed project is a direct to Phase 2 SBIR building on existing feasibility research that will be complete in Dec. 2025. The Phase 1 equivalent IRB approved device feasibility study has demonstrated, in a longitudinal setting, the efficacy of the AR-BCI-AI combination technologies. The proposed Phase 2 clinical study will similarly utilize a longitudinal experiment design. Each study participant will be provided with three communication solutions: letterboard (control), the AR-BCI device and a low encumbrance BCI-tablet configuration. The study will systematically evaluate the usability, feasibility, and utility of two candidate device configurations which both feature three input modalities: eye tracking, hybrid eye tracking/BCI, and pure BCI. This research is essential to finalize the product requirements and design in preparation for a pivotal study and FDA clearance. The anticipated outcomes of this research include demonstrating the effectiveness of the Cognixion ONE device in restoring communication for individuals with severe communication impairments, improving their quality of life, and potentially enhancing mental health. The project aligns with Cognixion’s mission to create transformative assistive technologies that empower individuals with disabilities. If successful, this device will have significant commercial applications in healthcare and home care settings, while also providing profound societal and scientific benefits by setting a new standard for communication aids in neurodegenerative conditions.