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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 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 Exclusion Criteria: * Morbid obesity (Body Mass Index \> 40) * History of poorly controlled seizures or epilepsy * Requires magnetic resonance imaging (MRI) for any ongoing medical conditions * Prior brain implant or active implanted medical device * Psychiatric disorder or cognitive impairment * Recent heart attack or cardiac arrest * Blood thinners that cannot be paused for surgery * 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
About the study
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.
What is being tested
- N1 Implant (device)
- R1 Robot (device)
Sponsor: Neuralink Corp · Participants: 10 · Started: 2026-11
Contact the study team
- Neuralink Clinical Team · Phone: (877) 398-4465
Official record on ClinicalTrials.gov — NCT07929792
Locations in the U.S.
| Florida | University of Miami, Miami |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.