VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
Recruiting
N/A
Interventional Study
Tetraplegia/Tetraparesis
Quadriplegia
Cervical Spinal Cord Injury
Amyotrophic Lateral Sclerosis
Quadriplegia/Tetraplegia
Tetraplegic; Paralysis
Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 6 (estimated)
- Sponsor
- Neuralink Corp · Industry
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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 ce…
Trial Locations
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Eligibility 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 …
Contacts