Trials / Recruiting
RecruitingNCT07224256
VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- Sponsor
- Neuralink Corp · Industry
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Tetraplegia/Tetraparesis
- Quadriplegia
- Cervical Spinal Cord Injury
- Amyotrophic Lateral Sclerosis
- Quadriplegia/Tetraplegia
- Tetraplegic; Paralysis
- Stroke
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-10-03
- Primary completion
- 2028-10-01
- Completion
- 2031-10-01
- First posted
- 2025-11-04
- Last updated
- 2025-11-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07224256. Inclusion in this directory is not an endorsement.