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

Neuralink Corp6 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Tetraplegia/Tetraparesis Quadriplegia Cervical Spinal Cord Injury Amyotrophic Lateral Sclerosis

Eligibility

Sex: ALLMin age: 22 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Device-Related Adverse Events (AE)

The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit.

Time frame: 12 months post-implant

Procedure-Related Adverse Events (AE)

The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit.

Time frame: 12 months post-implant

Secondary Outcomes

Long-term Device-Related Adverse Events (AE)

The proportion of subjects with device-related adverse events (AEs) up to the 48-month long-term follow-up visit.

Time frame: Up to 48 months post-implant

Long-term Procedure-Related Adverse Events (AE)

The proportion of subjects with procedure-related adverse events (AEs) up to the 48-month follow-up visit.

Time frame: Up to 48 months post-implant

Preliminary efficacy of the R1 Robot

Preliminary efficacy of the R1 Robot will be evaluated by measuring the following percent of electrodes inserted (reported as electrodes inserted / total electrodes).

Time frame: During surgical implantation procedure

Preliminary efficacy of the N1 Implant

Preliminary efficacy of the N1 Implant will be evaluated by measuring the following BCI performance for speech, quantified by measuring the monthly maximum correct word per minute (CWPM).

Time frame: Up to 48 months post-implant

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts