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NCT06429735 · ClinicalTrials.gov registry record · NA

Precise Robotically IMplanted Brain-Computer InterfacE

A NA study of Amyotrophic Lateral Sclerosis and Cervical Spinal Cord Injury, sponsored by Neuralink.

Recruiting
Registry status
NA
Development phase
15
Enrollment target
2
Study locations

NCT06429735 is a NA study of Amyotrophic Lateral Sclerosis and Cervical Spinal Cord Injury that is actively recruiting participants, run by Neuralink. The registered enrollment target is 15 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT06429735, a NA study of Amyotrophic Lateral Sclerosis and Cervical Spinal Cord Injury, is actively recruiting participants, sponsored by Neuralink.

RECRUITING
Registry status
NA
Development phase
15 participants
Enrollment target
2
Study locations

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 Studied

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

Interventions

  • DEVICE N1 Implant
  • DEVICE R1 Robot

Study Locations (2)

Arizona

  • Barrow Neurological Institute - Phoenix

Florida

  • University of Miami - Miami

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2024-01-09
Est. Completion 2031-01
Phase NA

Sponsor

Neuralink

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06429735

The ClinicalTrials.gov registry entry for NCT06429735 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The listed sponsor is Neuralink, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which N1 Implant is the first listed.

NCT06429735 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT06429735 about?

NCT06429735 is a clinical study titled "Precise Robotically IMplanted Brain-Computer InterfacE". 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 con...

What is the current status of trial NCT06429735?

This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2024-01-09. Estimated completion is 2031-01.

What conditions does trial NCT06429735 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis, Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia.

What interventions are being tested in trial NCT06429735?

The interventions under investigation include: N1 Implant (DEVICE), R1 Robot (DEVICE).

Who is sponsoring clinical trial NCT06429735?

This trial is sponsored by Neuralink, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06429735 being conducted?

This trial has 2 study locations across Arizona, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.