Neuralink Corp., the brain implant startup led by billionaire Elon Musk has started recruiting patients for a clinical trial.
In a blog post, the company said that it has received approval from the reviewing independent institutional review board and its first hospital site to begin recruitment for the first-in-human clinical trial.
The PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface) – a groundbreaking investigational medical device trial for our fully-implantable, wireless brain-computer interface (BCI) – aims to evaluate the safety of our implant (N1) and surgical robot (R1) and assess the initial functionality of our BCI for enabling people with paralysis to control external devices with their thoughts, the company said.
We're excited to announce that recruitment is open for our first-in-human clinical trial!
September 19, 2023
If you have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS), you may qualify. Learn more about our trial by visiting our recent blog post.…During the study, the R1 Robot will be used to surgically place the N1 Implant's ultra-fine and flexible threads in a region of the brain that controls movement intention.
Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention, Neuralink said.
The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone, the company said.
Neuralink said that the PRIME Study is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023 and represents an important step in our mission to create a generalized brain interface to restore autonomy to those with unmet medical needs.
Those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify.
Neuralink Clinical Trial: Compensation
The company will compensate patients for study-related costs (such as travel expenses to and from the study site).
Neuralink Clinical Trial: Eligibility
Neuralink is looking for individuals who:
Have quadriplegia (limited function in all 4 limbs) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) and are at least 1-year post-injury (without improvement)
Are at least 22 years old
Have a consistent and reliable caregiver
The following individuals are not eligible:
Individuals those who have an active implanted device (pacemaker, deep brain stimulator (DBS), etc.)
Individuals who have a history of seizures
Individuals who require MRIs for an ongoing medical condition
Indivisuals who are receiving transcranial magnetic stimulation (TMS) treatment
Neuralink Clinical Trial: Time Duration
The study will take approximately 6 years to complete. During the study, patients will have regular follow-ups with Neuralink's team of experts to monitor their progress and ensure the Neuralink BCI continues to work as intended.
For more details about the Neuralink clinical trail, click here.
According to a Bloomberg report, the announcement marks a highly anticipated moment for the startup, which has created a wave of interest in the field of brain implants.
While Musk has discussed far-out targets for Neuralink — such as helping people learn languages or communicating thoughts mentally — he has also consistently said that its first project would be to help ameliorate brain injuries, the report said.
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