Tetraplegia/TetraparesisPRIMENCT06429735
Precise Robotically IMplanted Brain-Computer InterfacE
A study testing N1 Implant and R1 Robot in people with Tetraplegia/Tetraparesis and Quadriplegia, run by Neuralink Corp at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury
- What is being tested?
- N1 Implant and R1 Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jan 2024to Jan 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Jonathan Jagid, MD
- Recruiting
Barrow Neurological Institute
Phoenix, Arizona, 85013
Francisco Ponce, MD
About this study
Official title: PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
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
- Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Quadriplegia/Tetraplegia, Tetraplegic; Paralysis
- Being tested
- N1 Implant, R1 Robot
- Keywords
- spinal cord injury, SCI, BCI, brain computer interface, ALS, quadriplegia, tetraplegic, paralysis
- Medical subject headings
- Quadriplegia, Amyotrophic Lateral Sclerosis, Paralysis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1 ImplantDevice
Also called Neuralink N1 Implant, N1, Telepathy, Link
The N1 Implant is a type of implantable brain-computer interface
R1 RobotDevice
Also called R1, Neuralink R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
| Study group | Role | What they receive |
|---|---|---|
| Neuralink N1 Implant and R1 Robot | Experimental | Implantation of the N1 Implant by the R1 Robot. Receives: Device: N1 Implant; Device: R1 Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-Related Adverse Events (AE)
Measured: 12 months post-implant
Procedure-Related Adverse Events (AE)
Measured: 12 months post-implant
Secondary outcomes (2)
Device-Related Adverse Events (AE)
Measured: Up to 72 months post-implant
Procedure-Related Adverse Events (AE)
Measured: Up to 72 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start9 Jan 2024
- Primary completionJun 2026 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetraplegia/TetraparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuralink Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Ponce, MD, Principal investigator, Barrow Neurological InstituteJonathan Jagid, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429735
- Sponsor's protocol ID
- N1-EFS-001
- Acronym
- PRIME
- Status last verified
- Jan 2026
- First submitted
- 21 May 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No