Precise Robotically IMplanted Brain-Computer InterfacE

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Neuralink Corp
Study ID
NCT06429735
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • N1 Implant — DEVICE
    The N1 Implant is a type of implantable brain-computer interface
  • R1 Robot — DEVICE
    The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Study Details

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.

Key Dates

Start date
Jan 9, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jan 31, 2031

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Neuralink N1 Implant and R1 Robot
    Implantation of the N1 Implant by the R1 Robot.

Primary Outcome Measure

Device-Related Adverse Events (AE) [ Time Frame: 12 months post-implant ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Barrow Neurological InstitutePhoenixArizona85013
Francisco Ponce, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Jonathan Jagid, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Barrow Neurological Institute· Phoenix, AZUniversity of Miami· Miami, FL

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