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OpenTrials
Enrolling by Invitation

NCT Number: NCT06710626

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.

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Key information

Conditions

Tetraplegia/Tetraparesis Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS) Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Paralysis Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Quadriplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury (SCI) Spinal Cord Injury Cervical TDP-43 Proteinopathies Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: BCI controlled robotic arm

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of Device-Related Adverse Events (AE)

    Time frame: Up to 72 months after enrollment

  2. 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

  3. Change in Assistive Technology Device Predisposition Assessment (ATD PA) Score

    Time frame: From enrollment, every 3 months, up to 72 months

Sponsors and collaborators

Lead sponsor

Neuralink Corp

Industry

Registry information

Official study title

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

Acronym: CONVOY

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Nov 29, 2024
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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