Control of Assistive Devices Via Brain-Computer Interface Technology (CONVOY)

Neuralink Corp

Status: Invitation-only

Conditions: Quadriplegia; Amyotrophic Lateral Sclerosis (ALS); Spinal Cord Injury Cervical; Tetraplegia/Tetraparesis; Spinal Cord Injury (SCI)

Treatments: Device: Assistive Robotic Arm

Study type: Interventional

Funder types: Industry

Identifiers

NCT06710626

N1-EFS-100

Details and patient eligibility

About

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.

Enrollment: 3 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.
• Explantation or deactivation of the N1 Implant.
• Lack of a suitable physical space to perform research sessions.
• Any condition which, in the opinion of the Investigator, would compromise the candidate's ability to safely participate in the study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Single

Other group

Treatment:

Device: Assistive Robotic Arm