VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: N1 Implant, R1 Robot.
- Who it may be relevant to
- Registry conditions: Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis. Basic parameters: 22 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment. It is indicated for adults with neurological conditions of the central speech pathways who have impaired upper limb function. 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.
Interventions
- Device N1 Implant
The N1 Implant is a type of implantable brain-computer interface - Device R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Primary outcome measures
- Device-Related Adverse Events (AE) [Time frame: 12 months post-implant]
- Procedure-Related Adverse Events (AE) [Time frame: 12 months post-implant]
Secondary outcome measures (4)
- Long-term Device-Related Adverse Events (AE) [Time frame: Up to 48 months post-implant]
- Long-term Procedure-Related Adverse Events (AE) [Time frame: Up to 48 months post-implant]
- Preliminary efficacy of the R1 Robot [Time frame: During surgical implantation procedure]
- Preliminary efficacy of the N1 Implant [Time frame: Up to 48 months post-implant]
Eligibility criteria
Inclusion criteria
Adults with diagnosis of ALS, PLS, stroke, or Spinal Cord Injury who have severe speech impairment and impaired upper limb function.
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- The University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT07224256 · N1-EFS-200