Brain implant for computer control after spinal cord injury, ALS or stroke
Tests the N1 brain implant in adults with severe arm weakness.
Key facts
- Who runs it
- Neuralink Corp
- Where
- Miami, United StatesSee the site
- Trial code
- Registry title
- An Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for Neural Control of External Devices in Spinal Cord Injury, Amyotrophic Lateral Sclerosis, and Chronic Ischemic Stroke
- Status
- Recruiting
- People taking part
- 10 people, planned
- Started
- Nov 2026
- Expected to end
- Nov 2031
- Type of study
- Interventional
- Treatments tested
- N1 Implant
- R1 Robot
- Record updated
- 12 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Adults with a diagnosis of ALS, spinal cord injury or chronic ischemic stroke who have severe weakness in the arms and hands that limits independent use of a computer or phone
- Stable medical, physical and psychological condition
- Ability to communicate verbally or with a communication aid
- A caregiver available when daily support is needed
Who cannot take part
- Prior brain implant or active implanted medical device
- Blood thinners that cannot be paused for surgery
- History of poorly controlled seizures or epilepsy
- Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
- Psychiatric disorder or cognitive impairment
- Recent heart attack or cardiac arrest
- Brain MRI or CT demonstrating hemorrhage, tumor, or distorted or adverse anatomy
- Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure
- Morbid obesity (Body Mass Index > 40)
Where in United States
- University of MiamiMiami, United StatesContact: Letitia FisherTaking people
About the trial
What the trial wants to find out
The purpose of this study is to evaluate the safety and preliminary effectiveness of the N1 System, a fully implanted brain-computer interface placed in the motor cortex with the R1 Robot. The study builds on knowledge gained in a previous clinical investigation of this system. It enrolls adults with severe upper-limb impairment from spinal cord injury, amyotrophic lateral sclerosis (ALS), or chronic ischemic stroke. Participants use neural signals recorded by the N1 Implant to control a computer cursor or virtual keyboard. The study will describe serious adverse device effects and will assess digital daily activities, computer-control performance, independent use of the system, and participant-, clinician-, and caregiver-reported outcomes. Up to 10 participants will be enrolled at up to five sites in the United States and followed for about 2 years after implantation, or about 3 years if they choose extended follow-up. There is no comparison group; each participant's results are compared with their own baseline.
The group in the trial
- Neuralink N1 Implant and R1 RobotTreatment being tested
Implantation of the N1 Implant by the R1 Robot.
Treatment: N1 Implant and R1 Robot
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for Neural Control of External Devices in Spinal Cord Injury, Amyotrophic Lateral Sclerosis, and Chronic Ischemic Stroke
- Plain-language title
- Brain implant for computer control after spinal cord injury, ALS or strokeGenerated from the registry record. The registry title is the official one.
- Record updated
- 12 November 2026