Control of Assistive Devices Via Brain-Computer Interface Technology

NCT ID: NCT06710626

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2031-05-25

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single

Group Type OTHER

Assistive Robotic Arm

Intervention Type DEVICE

The intervention involves using the N1 Implant, a wireless brain-computer interface (BCI), to enable participants to control the Assistive Robotic Arm through neural signals.

Interventions

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Assistive Robotic Arm

The intervention involves using the N1 Implant, a wireless brain-computer interface (BCI), to enable participants to control the Assistive Robotic Arm through neural signals.

Intervention Type DEVICE

Other Intervention Names

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BCI controlled robotic arm

Eligibility Criteria

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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.
* Any condition which, in the opinion of the Investigator, would compromise the candidate's ability to safely participate in the study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neuralink Corp

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

Countries

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United States

Related Links

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https://neuralink.com/

Neuralink Website

Other Identifiers

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N1-EFS-100

Identifier Type: -

Identifier Source: org_study_id

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