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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06429735
Other study ID # N1-EFS-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 9, 2024
Est. completion date January 2031

Study information

Verified date June 2024
Source Neuralink Corp
Contact Head of Clinical
Phone (877) 398-4465
Email clinical-team-ct@neuralink.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3
Est. completion date January 2031
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 22 Years to 75 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria - 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 - History of poorly controlled diabetes - Requires magnetic resonance imaging (MRI) for any ongoing medical conditions - Acquired or hereditary immunosuppression - Use of smoking tobacco or other tobacco products - Psychiatric or psychological disorder - Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy. - Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure

Study Design


Intervention

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

Locations

Country Name City State
United States Barrow Neurological Institute Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Neuralink Corp

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Device-Related Adverse Events (AE) 12 months post-implant
Primary Procedure-Related Adverse Events (AE) 12 months post-implant
Secondary Device-Related Adverse Events (AE) Up to 72 months post-implant
Secondary Procedure-Related Adverse Events (AE) Up to 72 months post-implant
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