The U.S. Food and Drug Administration has approved a clinical trial using a neuroimaging helmet made by Los Angeles-based Kernel to track what happens in the brain when a human takes a psychedelic dose of ketamine.
Cybin, a Toronto-based psychedelic therapeutics startup, is sponsoring the study. The study will begin before the end of the year with 15 patients at a ketamine-assisted therapy clinic in Marina Del Rey, California. All patients will go through two rounds of the trial. The first one will be a placebo session with saline solution so the Kernel Flow brain-imaging device can get a baseline for the patient’s neurological activity and the second session patients will get an intramuscular injection of a psychedelic dose of ketamine while wearing the Kernel Flow headset…
“We’re trying to open up the black box of human cognition, experience and feeling to understand what is happening in the brain when people are having a psychedelic state of consciousness,” says Belser, who is a licensed psychologist and a psychedelic researcher at Yale University. “We can measure that for the first time meaningfully, in real time, with a wearable” …
For Cybin, which is also developing novel psychedelic molecules they hope to bring to market as FDA-approved medicines for mental health issues like depression and substance use disorder, the Kernel Flow might be able to guide their drug development.
Cybin, a biotechnology company focused on progressing psychedelic therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has authorized an Investigational New Drug (IND) application to proceed with the Company’s sponsored feasibility study using Kernel’s Flow technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.
“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. 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,” said Dr. Alex Belser, Cybin’s Chief Clinical Officer…
“Quantitatively measuring the brain within the context of a psychedelic experience is a promising frontier,” said Bryan Johnson, founder and Chief Executive Officer of Kernel. “With Kernel Flow, Cybin’s researchers can start putting numbers and quantification to subjective states of mind, including altered ones.”
Kernel Flow uses pulsed light instead of continuous wave light to increase measured brain information. In contrast with electroencephalography (“EEG”) electrodes that usually require gel on the head or functional magnetic resonance imaging (“fMRI”) studies that require a participant to lie in a scanner, Kernel Flow is easily wearable. The entire system is the size and look of a bicycle helmet and could, in the future, be more broadly used for neuroscientific or physiological studies of brain activity during psychedelic use.
News in Context:
- Kernel raises $53 million to ease access to rich neural data and market Neuroscience as a Service (NaaS)
- Beacon Biosignals raises $27M to scale EEG, AI-based neurobiomarker discovery platform
- Machine-learning study finds EEG brain signatures that predict response to antidepressant treatments
- Cumulus Neuroscience raises $8.3M to develop EEG-based wireless ‘Fitbit for the brain’
- New report: Empowering 8 Billion Minds via Ethical Development and Adoption of Neurotechnologies