On January 18, 2023, Cybin Inc., a leading biopharmaceutical firm focused on advancing Psychedelics to Therapeutics®, announced the key findings from a feasibility study undertaken by its partner Kernel, which evaluated Kernel's Flow® wearable technology to assess ketamine's psychedelic effect on cerebral cortex hemodynamics. The findings of this Cybin-sponsored study are meant to guide the program's future direction.
The key highlights of the feasibility study are
It offered important proof-of-concept for Kernel Flow as a portable functional system that delivers real-time measurements of blood oxygenation changes in the brain linked with neural activity utilizing Time Domain Near Infrared Spectroscopy (TD-fNIRS).
Exhibited changes in functional brain biomarkers caused by ketamine that are related to potential therapeutic effects, including changes in cortical function associated with psychedelic experiences.
Compared to saline, ketamine reduces the global brain connectivity of the prefrontal region and decreases the brain-wide fractional amplitude of low-frequency fluctuations (fALFF). It has been proposed that fALFF is of particular functional significance within the default mode network, which has been demonstrated to be modulated by psychedelics and is associated with several neuropsychiatric conditions.
A model incorporating neurological and physiological metrics successfully predicted mystical experience scores on the Revised Mystical Experience Questionnaire, which has been shown to mediate reductions in depressive symptomatology in prior studies.
Displayed reliable pulse rate variability (PRV) and physiological measurements of pulse rate (PR) from TD-fNIRS recordings that correspond to those obtained from commercial external photoplethysmography sensors, thereby eliminating the need for external sensors to measure cardiac activity in future experiments.
Ketamine increased PR, decreased PRV, increased absolute oxy-hemoglobin concentrations and decreased deoxy-hemoglobin concentrations while increasing electrodermal activity (measured by an external sensor), providing additional physiological measures of the impact of the ketamine doses administered in the study.
The main goal of the feasibility study was to find out how people who had been given ketamine felt about wearing Kernel Flow while in an altered state of consciousness.
The feasibility study was granted FDA Investigational New Drug approval in October 2021 and US Institutional Review Board approval in January 2022.
About Cybin
Founded in 2019 and headquartered in Canada, Cybin is a biotechnology company that develops psychedelic pharmaceutical treatments for a variety of psychiatric and neurological disorders. It collaborates with a network of world-class partners and internationally recognized scientists to develop safe and effective treatments for patients dealing with a wide range of mental health conditions. The company is currently operating in the United States, Canada, the United Kingdom, Ireland, and the Netherlands.