COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

The Synchron motor neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility.

The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neurologic Disorder Amyotrophic Lateral Sclerosis Brain Diseases Brain Infarction Brain Ischemia Brain Stem Infarctions Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Cervical Spinal Cord Injury Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Infarction Ischemia Ischemic Stroke Metabolic Diseases Motor Neuron Disease Muscular Atrophy, Spinal Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Necrosis Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Paralysis Paralysis; Stroke Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Quadriplegia Quadriplegia/Tetraplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Muscular Atrophy Stroke Stroke Brainstem Stroke, Lacunar TDP-43 Proteinopathies Tetraplegic; Paralysis Thrombotic Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo Neurosurgery (UBNS), Buffalo, New York, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Severe quadriparesis
Able to give consent
Appropriate candidate for neurointerventional procedure
Able and willing to access all clinical testing and not impeded by geographical location
Proficient in English
Have a study partner

Exclusion criteria

Active condition resulting in immunosuppression
Unsuitable for general anesthesia
Anaphylactic allergy to contrast media
Allergy to nickel
History of pulmonary embolism
History of recent deep vein thrombosis
Psychiatric or psychological disorder
No study partner or caregiver
Unable to provide evidence of COVID vaccination

Treatment and study plan

Motor Neuroprosthesis (MNP)

Device

Type of implantable brain computer interface

Primary outcomes

Treatment-Related Serious Adverse Events

Time frame: 12 months post implant

Number of subjects with treatment-related adverse events

Sponsors and collaborators

Lead sponsor

Synchron Medical, Inc.

Industry

Registry information

Official study title

Motor NeuroProsthesis to Restore Motor Control for the COMMAND of Digital Devices: An Early Feasibility Study (EFS) of Safety in Subjects With Severe Quadriparesis

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2026
First posted: Sep 5, 2021
Registry last updated: Apr 29, 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.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting