FDA Authorizes Cybin Device to Quantify Psychedelics’ Effects on the Brain

We may be on a new frontier of understanding for psychedelic therapies, with the Food and Drug Administration (FDA) authorizing a neuroimaging device that may allow researchers to quantify psychedelics’ effects on the brain, in real-time.

The Kernel Flow device, developed by neurotech company Kernel in partnership with Canadian biotechnology company Cybin, will be used in a feasibility study to measure ketamine’s psychedelic effects on the brain, specifically cerebral cortex hemodynamics.

The device is the first-of-its-kind to leverage neuroimaging to measure brain activity in real-time using a wearable helmet (that resembles a bicycle helmet) during psychedelic treatments.

Cybin, which is sponsoring the study, believes that Kernel Flow can enable the acquisition of information about longitudinal brain activity before, during, and after a psychedelic experience. This would quantify the effects of psychedelics—data that was previously only available as subjective patient reporting.   

“The word psychedelic means ‘mind-manifesting,’ but what has been missing is useful ‘mind-imaging’—the ability to dynamically trace the neural correlates of human conscious experience,” Cybin’s Chief Clinical Officer Dr. Alex Belser explained with today’s announcement. “Conventional neuroimaging just isn’t dynamic enough to study the psychedelic experience in the brain as it happens. This study of ketamine’s psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding.”

Kernel Flow uses pulsed light to increase measured brain information. Unlike other tests that measure brain activity, such as electroencephalography, which requires electrodes to be placed on the head with a gel, or functional magnetic resonance imaging (fMRI), which requires participants to lie down in a scanner, Kernel Flow is wearable. This may provide an advantage for future neuroscientific or physiological studies of brain activity during psychedelic use.

To date, direct neuroimaging of psychedelic effects has rarely been attempted. For studies in 2012, 2013, and 2014, researchers used neuroimaging techniques such as fMRI and magnetoencephalography (MEG) to understand how classic psychedelics such as psilocybin and psilocin affect the brain. A 2016 study combined three neuroimaging techniques—arterial spin labeling (ASL), blood oxygen level-dependent (BOLD) measures, and MEG—in a bid to understand changes in brain activity caused by LSD.

However, none of these previous studies involved the use of a wearable device that could provide researchers real-time data illuminating psychedelics’ effects on the brain.

“We hope this feasibility study can bridge the gap of real-time quantitative data collection during psychedelic treatments to further understand the correlation of effects from these powerful molecules,” said Cybin CEO Doug Drysdale. “The ability to access real-time brain activity data during a psychedelic experience has tremendous potential for the development of future psychedelic therapeutics.”