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

June 2, 2025 updated by: Neuralink Corp

CONVOY: An Early Feasibility Study of Neural Control of Assistive Devices Via Brain-Computer Interface Technology

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single
Device: 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.
Other Names:
  • BCI controlled robotic arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ability of participants to modulate brain activity for controlling an assistive device via the N1 Implant.
Time Frame: 3-months following first use of the assistive device
3-months following first use of the assistive device

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of Device-Related Adverse Events (AE)
Time Frame: Up to 72 months after enrollment
Up to 72 months after enrollment
Assessment of Quality of Life Using the Psychosocial Impact of Assistive Devices Scale (PIADS)
Time Frame: From enrollment, every 3 months, up to 72 months
From enrollment, every 3 months, up to 72 months
Change in Assistive Technology Device Predisposition Assessment (ATD PA) Score
Time Frame: From enrollment, every 3 months, up to 72 months
From enrollment, every 3 months, up to 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuralink Corp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2024

Primary Completion (Estimated)

May 25, 2031

Study Completion (Estimated)

May 25, 2031

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N1-EFS-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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