Health TrialsbyHealthPanel

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

ConditionsTetraplegia/TetraparesisQuadriplegiaCervical Spinal Cord InjuryAmyotrophic Lateral SclerosisQuadriplegia/TetraplegiaTetraplegic; ParalysisStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorNeuralink Corp

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Life expectancy ≥ 12 months.

Ability to communicate in English

Presence of a stable caregiver

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • N1 Implant

    Device

    The N1 Implant is a type of implantable brain-computer interface

  • R1 Robot

    Device

    The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Neuralink N1 Implant and R1 RobotExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Device-Related Adverse Events (AE)

The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit.

Time frame
12 months post-implant
2

Procedure-Related Adverse Events (AE)

The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit.

Time frame
12 months post-implant

Secondary outcomes

1

Long-term Device-Related Adverse Events (AE)

The proportion of subjects with device-related adverse events (AEs) up to the 48-month long-term follow-up visit.

Time frame
Up to 48 months post-implant
2

Long-term Procedure-Related Adverse Events (AE)

The proportion of subjects with procedure-related adverse events (AEs) up to the 48-month follow-up visit.

Time frame
Up to 48 months post-implant
3

Preliminary efficacy of the R1 Robot

Preliminary efficacy of the R1 Robot will be evaluated by measuring the following percent of electrodes inserted (reported as electrodes inserted / total electrodes).

Time frame
During surgical implantation procedure
4

Preliminary efficacy of the N1 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).

Time frame
Up to 48 months post-implant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neuralink Corp

Lead sponsor

Source ClinicalTrials.gov
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