Brain-Computer Interface for ALS
(CONVOY Trial)

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Neuralink Corp

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices. The main goal is to determine whether participants can successfully modulate their brain activity to control devices, such as an Assistive Robotic Arm (ARA). This study will assess the effectiveness, consistency, and safety of neural control using the ARA and other assistive devices.

Research Team

Eligibility Criteria

This trial is for individuals with severe mobility impairments due to conditions like quadriplegia, spinal cord injury, or ALS. Participants should have previously been part of the PRIME Study and are now looking to test controlling assistive devices using their brain activity.

Inclusion Criteria

Continued enrollment in the PRIME Study

Implanted with the N1 Implant

Exclusion Criteria

Explantation or deactivation of the N1 Implant

Insufficient N1 Implant BCI performance demonstrated

Lack of a suitable physical space to perform research sessions

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Treatment Details

Interventions

N1 Implant (Brain-Computer Interface)

Trial OverviewThe CONVOY Study tests if participants can use the N1 Implant from a prior study to control an Assistive Robotic Arm (ARA) and other devices by modulating brain activity. It aims to evaluate how effective, consistent, and safe this neural control is.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: SingleExperimental Treatment1 Intervention

N1 Implant is already approved in Canada for the following indications: