FDA-approved, Cybin-sponsored clinicial trial to measure ketamine’s impact on the brain via Kernel Flow neuroimaging helmet

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Kernel’s Brain-Imag­ing Hel­met Approved For Clin­i­cal Tri­al On Patients Using Ket­a­mine (Forbes):

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.

The Announcement:

Cybin Announces FDA Inves­ti­ga­tion­al New Drug Autho­riza­tion of Cybin’s Spon­sored Fea­si­bil­i­ty Study Using Ker­nel Flow Tech­nol­o­gy (press release):

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.

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