VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
NCT ID: NCT07224256
Last Updated: 2025-11-04
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
2025-10-03
2031-10-31
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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Neuralink N1 Implant and R1 Robot
Implantation of the N1 Implant by the R1 Robot.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Life expectancy ≥ 12 months.
* Ability to communicate in English
* Presence of a stable caregiver
Exclusion Criteria
* 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
* 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
22 Years
75 Years
ALL
No
Sponsors
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Neuralink Corp
INDUSTRY
Responsible Party
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Principal Investigators
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Nader Pouratian, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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https://neuralink.com/
Other Identifiers
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N1-EFS-200
Identifier Type: -
Identifier Source: org_study_id
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