Neuralink has commenced recruitment for the first-in-human clinical trial of its brain-computer interface (BCI) project, a breakthrough technology aimed at enabling humans to control external devices using their thoughts alone.
The development comes after the Elon Musk-founded neurotechnology company received approval from the “independent institutional review board” to test its brain-computer interface (BCI) in humans.
“We are happy to announce that we’ve received approval from the independent institutional review board and our first hospital site to begin recruitment for our first-in-human clinical trial.”
Following the approval granted on Sept. 19, Neuralink has opened recruitment for the investigational medical device trial. Only those with specific illnesses such as deafness, vision loss and inability to speak can apply to take part in the impending trial exercise.
The announcement further revealed that “those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify.”
Neuralink Brain-Computer Interface (BCI) Clinical Trial
Codenamed PRIME Study, its primary objective is to assess the safety of the medical device and surgical robot. The forthcoming first-in-human clinical trial is also designed to assess the competence of Neuralink’s brain-computer interface in enabling paralytic patients to control external devices with their thoughts.
Describing the process of the clinical trial, the company submitted that the brain chip (dubbed Implant) will be installed in the region of the human brain that controls movement intention. This will be done with the aid of Neuralink’s surgical robot. It bears mentioning that the Implant is designed to record and transmit brain signals wirelessly to a designated application that decodes movement intention.
Conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023, the success of this groundbreaking clinical trial would enable Neuralink’s fully implantable, wireless brain-computer interface (BCI) to go mainstream.
According to the company, this breakthrough technology for the brain intends to give humans the ability to control a computer cursor or keyboard with their thoughts. Ultimately, Elon Musk‘s Neuralink is on a mission to restore autonomy to those with unmet medical needs using brain-computer interfaces.
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