VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration

Neuralink Corp

Status: Enrolling

Conditions: Stroke; Amyotrophic Lateral Sclerosis; Quadriplegia; Cervical Spinal Cord Injury; Tetraplegia/Tetraparesis; Quadriplegia/Tetraplegia; Tetraplegic; Paralysis

Treatments: Device: N1 Implant; Device: R1 Robot

Study type: Interventional

Funder types: Industry

Identifiers

NCT07224256

N1-EFS-200

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Neuralink N1 Implant and R1 Robot

Experimental group

Description:

Implantation of the N1 Implant by the R1 Robot.

Treatment:

Device: R1 Robot

Device: N1 Implant