Health TrialsbyHealthPanel

Precise Robotically IMplanted Brain-Computer InterfacE

ConditionsTetraplegia/TetraparesisQuadriplegiaCervical Spinal Cord InjuryAmyotrophic Lateral SclerosisQuadriplegia/TetraplegiaTetraplegic; Paralysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorNeuralink Corp

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below

Life expectancy ≥ 12 months.

Ability to communicate in English

Presence of a stable caregiver

Disqualifiers

Moderate to high risk for serious perioperative adverse events

Active implanted devices

Morbid obesity (Body Mass Index > 40)

History of poorly controlled seizures or epilepsy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Neuralink N1 Implant and R1 RobotExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Device-Related Adverse Events (AE)

Time frame
12 months post-implant
2

Procedure-Related Adverse Events (AE)

Time frame
12 months post-implant

Secondary outcomes

1

Device-Related Adverse Events (AE)

Time frame
Up to 72 months post-implant
2

Procedure-Related Adverse Events (AE)

Time frame
Up to 72 months post-implant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neuralink Corp

Lead sponsor

Source ClinicalTrials.gov
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