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Precise Robotically IMplanted Brain-Computer InterfacE

Study acronym: PRIME
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 9, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Enrollment target: 10 to 15 Primary completion date: Jan 2026 to Jun 2026v10 Show 1 more changeShow less
    • Primary completion date: Jan 2026 to Jun 2026
  2. Enrollment target: 5 to 10v9
  3. 2 versions Re-verified since Jan 27, 2025, no change to tracked fieldsv7-v8
  4. Study sites: 1 to 2v6
  5. Enrollment target: 3 to 5 Site contact updatedv5 Show 1 more changeShow less
    • Site contact updated
Show 3 earlier versionsHide 3 earlier versions
  1. Study Identification, Study Status, Contacts/Locationsv4
  2. Re-verified, no change to tracked fieldsv3
  3. Study Status, Referencesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Neuralink Corp
6 trials monitored
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ALS
387 trials monitored
See 18 trials at risk
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.
Trial Details
NCT Number NCT06429735
Lead Sponsor Neuralink Corp
Conditions Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Quadriplegia/Tetraplegia, Tetraplegic; Paralysis
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov