Control of Assistive Devices Via Brain-Computer Interface Technology

NCT06710626 | Enrolling By Invitation FDA Device

• 1 other identifier: N1-EFS-100
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

brain computer interface; robotic arm; assistive device; Neuralink N1 Implant; Neuralink; N1 Implant; ALS; Spinal cord injury; Quadriplegia; tetraplegia; Robot; external device control; neuroprosthetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Single

OTHER

Device: Assistive Robotic Arm

Interventions

Assistive Robotic Arm 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.

Also known as: BCI controlled robotic arm

Single

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuralink Corp: lead

Study Sites (1)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Related Links

• Neuralink Website

MeSH Terms

Conditions

Quadriplegia; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS).

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): May 25, 2031
• Study Completion (Estimated): May 25, 2031
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (1)