Neuralink still recruiting patients for its clinical trials: The PRIME Study

(Credit: Neuralink)

Neuralink is still recruiting patients for its human clinical trials, The PRIME Study. PRIME stands for Precise Robotically Implanted Brain-Computer Interface. Neurlink’s prime study will test the company’s brain-computer interface (BCI) by evaluating the company’s N1 implant and R1 surgical robot. 

The R1 surgical robot enables Neurlink to place its N1 implant into the region of the brain that controls movement. The surgical placement of N1 is delicate since the implant contains ultra-fine, flexible threads. Neuralink’s N1 implant should enable people with paralysis to control external devices, like cellphones or computers, with their thoughts.

Below are the qualifications Neuralink has for patients who wish to enroll in its PRIME Study. 

  • Persons that 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) 
  • Participants must be at least 22 years old. 
  • Participants must have a consistent and reliable caregiver.

Neuralink cannot accept the following individuals for the PRIME Study: 

  • Patients with an active implanted device (pacemaker, deep brain stimulator (DBS), etc.) 
  • Individuals who have a history of seizures 
  • Persons who require MRIs for an ongoing medical condition 
  • Persons who are receiving transcranial magnetic

The PRIME Study will last approximately 6 years, so individuals who wish to participate in Neuralink’s human clinical trials must be prepared for a long-term commitment. The trial is split into two parts. The Primary Study will take approximately 18 months, consisting of 9 at-home and in-person clinic visits. Neuralink PRIME Study patients must be prepared to participate in 1-hour BCI research sessions at least 2 times per week. 

After the 18-month Primary Study, Nueralink patients will enter the long-term follow-up phase of the human clinical trials. This phase lasts over 5 years, consisting of a total of 20 visits. 

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Neuralink still recruiting patients for its clinical trials: The PRIME Study
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