Neuralink received permission in May from the U.S. Food and Drug Administration (FDA) to test its technology on humans, which the company hopes can help people with paralysis due to cervical spinal cord injury or amyotrophic lateral sclerosis qualify for the study.
Revealing how the trial will run, Neuralink said the study will use a robot to surgically place a brain-computer interface implant in a region of the brain that controls the intention to move, adding that its initial goal is to enable people to control a computer cursor or keyboard using their thoughts alone.
The report read, “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.
“It aims to evaluate the safety of our implant and surgical robot and assess the initial functionality of our wireless Brain-Computer Interface (BCI) and enable people with paralysis to control external devices with their thoughts.
“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”.
However, Neuralink did not indicate the required number of persons for the trial.
As of September, no BCI company has managed to clinch the FDA’s final seal of approval. But by receiving the go-ahead to recruit for a study with human patients, Neuralink is one step closer.