Kernel’s Brain-Imaging Helmet Approved For Clinical Trial On Patients Using Ketamine

Your brain on drugs: Psychedelic therapeutic Cybin and neuroimaging technology startup Kernel will examine patients' brains while they are taking ketamine.

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The U.S. Food and Drug Administration has approved a clinical trial using a Los Angeles-based Kernel neuroimaging helmet to track what happens in the brain when a person takes a psychedelic dose of ketamine.

Cybin, a Toronto-based psychedelic therapeutic startup, is sponsoring the study. The study will begin before the end of the year in 15 patients at a ketamine-assisted therapy clinic in Marina Del Rey, California. All patients go through two rounds of the study. The first will be a placebo session of saline so that the Kernel Flow brain imaging device can get a baseline of the patient's neurological activity, and the second session will give patients an intramuscular injection of a psychedelic dose of ketamine while doing the Kernel Flow. Wear a headset.

Alex Belser, Cybin's Chief Clinical Officer, has studied psychedelics for two decades and has conducted clinical trials of psilocybin and MDMA as potential treatments for depression, substance use, post-traumatic stress disorder, and obsessive-compulsive disorder.

"We are trying to open the black box of human cognition, experience and emotion to understand what happens in the brain when people are in a psychedelic state of consciousness," says Belser, a licensed psychologist and psychedelics researcher at Yale University. “For the first time, we can measure this in real time with a wearable. And we can measure how different areas of the brain may relate to other areas to understand and tell the story of how mind-manifesting drugs actually manifest in the mind. "

For the most part, the effects of psychedelic substances on patients with mental health problems such as depression and post-traumatic stress disorder depend heavily on the patient's subjective self-assessment. Cybin and Kernel hope to use the data from a patient's brain to better understand why psychedelic substances like ketamine and, ultimately, psilocybin and other molecules seem to help people with depression and other problems.

The reason why psychedelic drugs in clinical trials alleviate the symptoms of depression and PTSD is probably due to the transmission of signals from the 5-HT-2A receptor, which triggers what is known as neuroplasticity. Neuroplasticity helps the brain make new neural connections that are believed to produce quick and sustained positive mood effects.

In a number of studies, psilocybin-assisted psychotherapy has resulted in an almost immediate reduction in symptoms of depression in some participants after a single high dose and an antidepressant effect that lasts for up to six months. Crosstalk between different brain regions has also been linked to potential benefits of psychedelics. However, more neurological data, particularly longitudinal data, is needed to measure whether and how these drugs are helping patients.

“You have different regions of the brain that talk to other regions under the influence of psychedelics,” says Belser. “For the first time, we would like to actually be able to measure this in real time. This could be one of the reasons why psychedelic medicine has proven so clinically effective and successful. "

Kernel was founded in 2016 by Bryan Johnson, who founded the mobile payment company Braintree and sold it to PayPal in 2013.

Brain imaging technologies like EEG, PET, and fMRI are certainly advanced and good at what they do. These are expensive and bulky and require the patient to sit still. The Kernel device, which is approximately the size of a bicycle helmet, can be worn while the patient naturally moves. By collecting enough data, Johnson hopes to identify biomarkers that will help define a healthy brain, much like we can define a healthy heart, liver, kidneys, and other organs.

Kernel Flow uses pulses of infrared light to track cortical hemodynamics, or in layman's terms, it uses lasers to track blood flow through the brain.

“We rely on metrology in everything we do in life, whether it's driving speed, temperature, our heart, or blood sugar levels,” says Johnson. “And one of the only things that we can't reliably measure is our brain, our mind. We can measure black holes, our calories and our steps, but the brain has eluded us. "

Mind reader: Bryan Johnson compares his creation, the Kernel Flow, to a "fitness tracker for the brain".

Courtesy of Kernel

Johnson wants his technology to develop statistical reference ranges so that people can track their mental health in the same way as sleep, calories, or blood sugar. Why he's partnered with Cybin to study the effects of psychedelic drugs, he says he believes in the potential of psychedelics as treatments for mental health and wellbeing, but wants more accurate brain imaging to guide therapeutic development .

"Psychedelics are this new frontier of possibility, and what could really help Shepherds in this new era is a reliable measurement," he says.

For anyone wondering why we need more brain measurement tools, Johnson envisions if scientists couldn't measure the body's immune response while developing Covid-19 vaccines and had to ask patients if they felt they did Vaccine works. “That would have been a disaster,” he says.

He hopes his device can help usher in a future where we can measure a person's mental health not by self-reporting symptoms, which he compares to throwing arrows at a board, but by tracking certain biomarkers in the brain .

“We cannot have this conversation with unbridled confidence,” he says. “We are careful, we are measured. We hope to be a helper and bring credibility to the effect . "

For Cybin, which is also developing novel psychedelic molecules that they hopefully want to market as FDA-cleared drugs for mental health problems like depression and substance use disorders, the Kernel Flow might be able to guide their drug development.

"It may be a new frontier in neuroscience and psychedelic medicine," says Belser.

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