UAE-PRIME Trial

What is the Neuralink N1 Implant and how does it work?

The Neuralink N1 Implant is a type of brain-computer interface (BCI). BCI’s allows individuals with severe paralysis and speech impairment to control devices and interact with the digital world using only their thoughts, restoring communication and independence. The Neuralink N1 Implant is a fully implantable, wireless BCI designed to help individuals with paralysis and speech impairment to control external devices and communicate more independently with their thoughts. The implant records brain signals via 1,024 electrodes distributed across ultra-thin threads, each finer than a human hair. The threads are precisely inserted into the brain using the Neuralink R1 Robot.

Once in place, the N1 Implant detects brain signals corresponding to intentions, such as intended movement or speech, and transmits them wirelessly to an external app. The app decodes these signals into digital commands, allowing direct communication between the brain and digital devices, using only thoughts.

Who is eligible for the UAE-PRIME trial?

Ideal candidates include adults (18+) with severe physical disabilities resulting in limited limb movement or speech. This may include people with:

• Tetraplegia or tetraparesis (partial or complete paralysis in both arms and legs)
• Chronic spinal cord injuries (sustained over a year ago)
• Long-term upper limb motor impairments following stroke
• ALS or other progressive neurodegenerative disorders
• Severe speech articulation impairments (inability to speak or form sentences).

Cognitive function must remain intact, with candidates able to produce motor-related thoughts or internal speech. All candidates will undergo a thorough screening process which will include psychological evaluations, brain imaging, and exclusion of major co-morbidities (such a traumatic brain injury, brain implants like VP shunts or DBS, uncontrolled diabetes, morbid obesity, or bleeding disorders).

What does the implantation procedure involve?

Implantation is a neurosurgical procedure which involves a small circular skull opening approximately 25 mm in diameter to fit around the body of the N1 Implant. The opening is created over a specific area of the brain and its location is determined pre-operatively using neuro-navigation guided by a functional MRI. After exposing the brain, the threads of the implant are robotically inserted into a small (~2x2 cm) exposed area.

The entire procedure takes approximately 3 to 4 hours, during which threads of the N1 Implant are inserted into the brain, the N1 Implant is fixated into the skull, and the incision is closed. Patients are generally discharged the next day.

What happens after implantation?

After implantation, patients will have routine BCI research sessions to practice using their N1 Implant. Patients are expected to:

• Use the device regularly at home for 12 months
• Attend three research sessions per week
• Optionally elect to continue using the device for up to three years in a follow-up period after the first year

After the first year, patients can choose to continue using, deactivate, or remove the implant based on medical outcomes and personal preferences.

What are the potential benefits?

This is a research study, and while there are no guaranteed benefits, participants may experience significant improvements in independence and digital communication, including the ability to:

• Control computers and smartphones using only thoughts
• Communicate digitally through the Neuralink app
• Reduce dependence on others for daily tasks.

For those with paralysis or impaired speech, the trial represents a transformational shift in autonomy and engagement with the world.