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

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Neuralink Corp
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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.
Trial Details
NCT Number NCT07224256
Lead Sponsor Neuralink Corp
Conditions Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Quadriplegia/Tetraplegia, Tetraplegic; Paralysis, Stroke
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov