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 (PRIME2)

November 5, 2026 updated by: Neuralink Corp

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Jonathan Jagid, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

● A diagnosis of: (A) Spinal cord injury (SCI) for at least 12 months with a muscle power grade of ≤ 3/5 in all muscles of the arms and hands principally innervated by C6-T1 nerve roots at the time of screening AND the Investigator confirms that bilateral upper-limb weakness prevents reliable, independent use of standard digital-access devices. OR (B) Amyotrophic lateral sclerosis (ALS) with

  1. Muscle power grade ≤4/5 at C5 in both arms; AND

  2. Muscle power grade ≤3/5 in all muscles of both arms and hands principally innervated by C6-T1 nerve roots, except that strength above 3/5 in individual C6-T1 muscle groups is permitted if both of the following are met:

    1. ALSFRS-R Item 4 (Handwriting) score ≤2; AND

    2. The Investigator confirms that bilateral upper-limb weakness prevents reliable, independent use of standard digital-access devices. OR (C) Chronic ischemic stroke, with the event occurring at least 12 months before screening, resulting in residual hemiparesis of the pre-morbid dominant upper extremity, with a completion time on the Nine-Hole Peg Test (9-HPT), per standardized protocol, that exceeds 3 standard deviations above the respective established age- and hand-specific normative mean completion times for both hands.

      • Age ≥ 18 years.
      • Stable medical, physical, and psychological condition as considered by the investigators.
      • Ability to communicate verbally or with the use of a computer or communication aid.
      • Willingness to comply with all study procedures and availability for the duration of the study.
      • If the participant requires daily continuous support from a personal caregiver, the presence of a caregiver throughout the study is mandatory.
      • Willingness and ability of a caregiver to monitor the participant for medical complications and behavioral changes, and respond to alerts regarding device function.
      • Presence of or willingness to acquire reliable internet.*
      • Willing and able to provide informed consent. *Sponsor will reimburse participants for the cost of reasonable high-speed internet as needed during participation in the study

      Exclusion Criteria:

      • ● History of poorly controlled seizures or epilepsy.

        • History of poorly controlled autonomic dysreflexia.

        • Morbid obesity (Body Mass Index > 40).

        • Current deep venous thrombosis or pulmonary embolism.

        • Diagnosis of acute myocardial infarction or cardiac arrest within the last 12 months.

        • Requires magnetic resonance imaging (MRI) for any ongoing medical conditions within the next year

        • Any implanted, or previously explanted, intracranial device, except where:

          1. the device is a marketed intracranial stent or other endovascular implant that is labeled MR Conditional, and the Neurosurgeon confirms during preoperative surgical planning that its location is compatible with the planned craniectomy and thread insertion trajectory; or
          2. the explanted device was not previously implanted in the same hemisphere as the hemisphere of interest for the implantation of the N1 Implant

        • Any active implanted devices including but not limited to cardiac pacemakers, cardiac defibrillators, diaphragmatic pacemakers, peripheral or central nerve stimulators*.

        • Currently receiving or may receive transcranial magnetic stimulation therapy, diathermy, electroconvulsive therapy, or transcranial ultrasound within the next year.

        • Pregnant or of child-bearing potential and not using or planning to use contraception during the period of study participation.

        • Presence of mild or greater cognitive impairment per neuropsychological assessments.

        • Psychotic illness or chronic psychiatric disorder, or major depression if untreated (Diagnosis of Axis I or Axis II).

        • Contraindication for preoperative MRI.

        • Preoperative brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.

        • History of gadolinium contrast allergy.

        • Any type of destruction and/or damage to the primary motor cortex region as determined by MRI.

        • Are blind.

        • Ongoing use of anticoagulant or antiplatelet medication that cannot be suspended perioperatively.

        • Receiving invasive mechanical ventilation without a tracheostomy that has been in place for at least 3 months, or without stable ventilator settings for at least 1 month prior to enrollment.

        • May require invasive mechanical ventilation within the next year, and does not intend to undergo tracheostomy or placement of a percutaneous endoscopic gastrostomy (PEG) tube if invasive ventilation becomes necessary.

        • Currently participating in an investigational study (device and/or pharmaceutical) within 30 days prior to entering this study, or such investigational treatment planned during the 24 months following enrollment, unless approved by Sponsor.

        • Anatomical or functional characteristics of the skull, meninges, and brain incompatible with the surgical approach and N1 Implant, as assessed by

      MRI or CT, specifically:

      • Outer skull-to-pia distance < 5.4 mm over region of interest.
      • Scalp thickness < 3 or > 20 mm over region of interest.
      • Imaging evidence of stroke in the planned implant cortical target (for stroke patient population).
      • Any condition, including serious co-morbidities such as major organ failure, which in the opinion of the Investigator, would compromise the participant's ability to safely participate in the study or undergo the implantation procedure. *Intrathecal baclofen pumps are exempt from this criterion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuralink N1 Implant and R1 Robot

Implantation of the N1 Implant by the R1 Robot.
Device: N1 Implant

The N1 Implant is a type of implantable brain-computer interface

Device: R1 Robot

The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious adverse device effects (SADEs)
Time Frame: From surgical implantation day ("Day 0") through the 90-day follow-up visit.

A description of all serious adverse device effects (SADEs) occurring during the primary study phase-from the time of surgical implantation through the 90-day follow-up visit-in all implanted participants.
From surgical implantation day ("Day 0") through the 90-day follow-up visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuralink Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2031

Study Registration Dates

First Submitted

October 28, 2026

First Submitted That Met QC Criteria

November 5, 2026

First Posted (Actual)

November 10, 2026

Study Record Updates

Last Update Posted (Actual)

November 10, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N1-EFS-300

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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