CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
NCT ID: NCT06700304
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
6 participants
INTERVENTIONAL
2024-11-20
2030-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface
Open label
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Life expectancy ≥ 12 months.
* Ability to communicate in English
* Presence of a stable caregiver
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Neuralink Corp
INDUSTRY
Responsible Party
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Locations
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University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Related Links
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Neuralink Website
Other Identifiers
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N1-EFS-002
Identifier Type: -
Identifier Source: org_study_id
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