Amyotrophic Lateral Sclerosis, Cervical Spinal Cord Injury, Quadriplegia, Quadriplegia/Tetraplegia, Stroke, Tetraplegia/Tetraparesis, Tetraplegic; Paralysis
Conditions
Keywords
stroke, spinal cord injury, SCI, ALS, brain computer interface, BCI, PLS, voice, speech, dysarthria, neuralink
Brief summary
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
DEVICEN1 Implant
The N1 Implant is a type of implantable brain-computer interface
DEVICER1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Sponsors
Neuralink Corp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-Related Adverse Events (AE) | 12 months post-implant | The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit. |
| Procedure-Related Adverse Events (AE) | 12 months post-implant | The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Device-Related Adverse Events (AE) | Up to 48 months post-implant | The proportion of subjects with device-related adverse events (AEs) up to the 48-month long-term follow-up visit. |
| Long-term Procedure-Related Adverse Events (AE) | Up to 48 months post-implant | The proportion of subjects with procedure-related adverse events (AEs) up to the 48-month follow-up visit. |
| Preliminary efficacy of the R1 Robot | During surgical implantation procedure | Preliminary efficacy of the R1 Robot will be evaluated by measuring the following percent of electrodes inserted (reported as electrodes inserted / total electrodes). |
| Preliminary efficacy of the N1 Implant | Up to 48 months post-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). |
Countries
United States
Contacts
Primary ContactNeuralink Clinical Team
Outcome results
None listed