Control of Assistive Devices Via Brain-Computer Interface Technology

Not Applicable

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

• Registration Number: NCT06710626
• Lead Sponsor: Neuralink Corp

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-25
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-29
• Last Update Posted: 2024-11-29
• Primary Completion: 2031-05-25
• Study Completion: 2031-05-25

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Continued enrollment in the PRIME Study.
• Implanted with the N1 Implant.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States