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Precise Robotically IMplanted Brain-Computer InterfacE

NCT06429735 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-09

No results posted yet for this study

Summary

The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.

Conditions

  • Tetraplegia/Tetraparesis
  • Quadriplegia
  • Cervical Spinal Cord Injury
  • Amyotrophic Lateral Sclerosis
  • Quadriplegia/Tetraplegia
  • Tetraplegic; Paralysis

Interventions

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.

Sponsors & Collaborators

  • Neuralink Corp

    lead INDUSTRY

Principal Investigators

  • Francisco Ponce, MD · Barrow Neurological Institute

  • Jonathan Jagid, MD · University of Miami

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2026-06-30
Completion
2031-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06429735 on ClinicalTrials.gov