RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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.

Locations (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, United States