Precise Robotically IMplanted Brain-Computer InterfacE

Amyotrophic Lateral Sclerosis Clinical Trial

— PRIME  

Official title:

PRIME: An Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for the Control of External Devices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06429735
• Other study ID #: N1-EFS-001
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Cervical Spinal Cord Injury
• Motor Neuron Disease
• Paralysis
• Quadriplegia
• Quadriplegia/Tetraplegia
• Spinal Cord Injuries
• Tetraplegia/Tetraparesis

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

External Links

•   https://neuralink.com/