PRIME Study (Neuralink Clinical Trial): Second Participant receives Implant 

On 2nd August 2024, Elon Musk announced that his firm Neuralink has implanted Brain-computer interface (BCI) device to a second participant. He said the procedure went well, the device is working well and hoped to perform BCI device implantation procedures on another eight participants by the year end depending upon regulatory approval.  

Brain-computer interface (BCI) decodes intended movement signals from brain activity to control external devices such as computers. 

On 28th January 2024, Noland Arbaugh became the first participant to receive Neuralink’s N1 implant. The procedure was successful. He has shown the ability to command an external device recently. This progress in Neuralink’s wireless BCI interface is considered a significant step towards improving quality of life (QoL) for people with quadriplegia due to Amyotrophic lateral sclerosis (ALS) or spinal cord injury (SCI). 

Precise Robotically IMplanted Brain-Computer InterfacE (PRIME) Study, commonly refered as “Neuralink Clinical Trial” is a first-in-human early feasibility study to assess the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with severe quadriplegia (or tetraplegia or paralysis involving all four limbs and torso) due to spinal cord injury or amyotrophic lateral sclerosis (ALS).  

The N1 Implant (or Neuralink N1 Implant, or N1, or Telepathy, or Link) is a type of implantable brain-computer interface. It is skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot. 

The R1 Robot (or R1, or Neuralink R1 Robot) is a robotic electrode thread inserter that implants the N1 Implant. 

The three components -N1 Implant (a BCI implant), the R1 Robot (a surgical robot), and N1 User App (BCI software) – enable individuals with paralysis to control external devices. 

During the study, the R1 Robot is used to surgically place the N1 Implant in a region of the brain that controls movement intention. The participants is asked to use the N1 Implant and N1 User App to control a computer and provide feedback about the system. 

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References:  

  1. Lex Fridman Podcast #438 – Transcript for Elon Musk: Neuralink and the Future of Humanity. Published 02 August 2024. Available at https://lexfridman.com/elon-musk-and-neuralink-team-transcript#chapter2_telepathy 
  1. Neuralink. PRIME Study progress update. Available at https://neuralink.com/blog/prime-study-progress-update/ 
  1. Barrow Neurological Institute. Press Releases – PRIME Study Site Announcement. 12 April 2024.Avaialable at https://www.barrowneuro.org/about/news-and-articles/press-releases/prime-study-site-announcement/ 
  1. Precise Robotically Implanted Brain-Computer Interface (PRIME) Study or Neuralink Clinical Trial. Clinical Trial No. NCT06429735. Available at https://clinicaltrials.gov/study/NCT06429735 
  1. Neuralink Clinical Trial Brochure. Available at https://neuralink.com/pdfs/PRIME-Study-Brochure.pdf 

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