Tetraplegia/TetraparesisCAN-PRIMENCT06700304
CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
A study testing N1 Implant and R1 Robot in people with Tetraplegia/Tetraparesis and Quadriplegia, run by Neuralink Corp at 1 site in Canada.
Trial summary
The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia
- 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
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2024to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- 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
Show all 11Show fewer
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Dr. Andres Lozano
About this study
Official title: CAN-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use.
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Injury (Quadraplegia)
- Being tested
- N1 Implant, R1 Robot
- Keywords
- brain computer interface, Neuralink N1 Implant, Neuralink, Robot, tetraparesis, tetraplegia, quadriplegia, ALS, spinal cord injury, Amyotrophic lateral sclerosis, chip, brain chip, External device control, Wireless implant, Neuroprosthetics, SCI, paralysis
- Medical subject headings
- Quadriplegia, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1 ImplantDevice
The N1 Implant is a type of implantable brain-computer interface.
R1 RobotDevice
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
| Study group | Role | What they receive |
|---|---|---|
| CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface | Other | Open label Receives: Device: N1 Implant; Device: R1 Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Device-Related Adverse Events (AE)
Measured: 12 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Measured: 12 months post-implant
Secondary outcomes (8)
The Rate of Device-Related Adverse Events (AE)
Measured: Up to 36 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Measured: Up to 36 months post-implant
Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study
Measured: From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase
Measured: From baseline to 36-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study
Measured: From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase
Measured: From baseline to 36-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study
Measured: From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase
Measured: From baseline to 36-months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start20 Nov 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2030 (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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuralink Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700304
- Sponsor's protocol ID
- N1-EFS-002
- Acronym
- CAN-PRIME
- Status last verified
- May 2025
- First submitted
- 15 Nov 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAN-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
- ClinicalTrials.gov ID
- NCT06700304
- Acronym / sponsor ID
- CAN-PRIME / N1-EFS-002
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Injury (Quadraplegia)
- Keywords
- brain computer interface, Neuralink N1 Implant, Neuralink, Robot, tetraparesis, tetraplegia, quadriplegia, ALS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Neuralink CorpIndustry (pharma, biotech, devices)
- Collaborators
- University Health Network, Toronto
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)
| Arm | Type | Receives |
|---|---|---|
| CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface | Other | Device: N1 Implant, Device: R1 RobotOpen label |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N1 ImplantThe N1 Implant is a type of implantable brain-computer interface. | Device | CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface |
| R1 RobotThe R1 Robot is a robotic electrode thread inserter that implants the N1 Implant. | Device | CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface |
Primary outcome
The Rate of Device-Related Adverse Events (AE)
Time frame: 12 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time frame: 12 months post-implant
8 secondary outcomes
The Rate of Device-Related Adverse Events (AE)
Time frame: Up to 36 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time frame: Up to 36 months post-implant
Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study
Time frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase
Time frame: From baseline to 36-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study
Time frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase
Time frame: From baseline to 36-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study
Time frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase
Time frame: From baseline to 36-months post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Neuralink WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Tetraplegia/Tetraparesis
Recruiting
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
Tetraplegia/Tetraparesis
Recruiting
Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)
Tetraplegia/Tetraparesis, Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Efficacy of Robotic Upper Limb Rehabilitation Training in Patients With Tetraplegia
Tetraplegia/Tetraparesis, Rehabilitation Treatment
Recruiting
Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia
Spinal Cord Injury Cervical, Tetraplegia/Tetraparesis
RecruitingEarly Phase 1
Spinal Cord Associative Plasticity Study
Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N1 Implant and R1 Robot in people with Tetraplegia/Tetraparesis and Quadriplegia, run by Neuralink Corp at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neuralink Clinical Team ((877) 398-4465, clinical-team-ct@neuralink.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Rate of Device-Related Adverse Events (AE) (time frame: 12 months post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.