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Clinical Trials in the USA / NCT05035823
Active, not recruiting Not applicable

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

NCT05035823 · tracked via the Priya Life Science USA tracker
Sponsor
Synchron Medical, Inc
Phase
Not applicable
Started
2022-04-27
Last updated
2026-09-08

Condition(s) studied

Neurologic DisorderParalysisParalysis; StrokeAmyotrophic Lateral SclerosisMuscular DystrophiesSpinal Cord InjuriesStroke, LacunarStroke BrainstemCervical Spinal Cord InjurySpinal Muscular AtrophyTetraplegic; ParalysisQuadriplegia/Tetraplegia

Investigational drug(s) / intervention(s)

Motor Neuroprosthesis (MNP)

Motor Neuroprosthesis (MNP): Type of implantable brain computer interface

Study summary

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Severe quadriparesis 2. Able to give consent 3. Appropriate candidate for neurointerventional procedure 4. Able and willing to access all clinical testing and not impeded by geographical location 5. Proficient in English 6. Have a study partner Exclusion Criteria: 1. Active condition resulting in immunosuppression 2. Unsuitable for general anesthesia 3. Anaphylactic allergy to contrast media 4. Allergy to nickel 5. History of pulmonary embolism 6. History of recent deep vein thrombosis 7. Psychiatric or psychological disorder 8. No study partner or caregiver 9. Unable to provide evidence of COVID vaccination

Primary outcome measure(s)

  • Treatment-Related Serious Adverse Events — 12 months post implant
    Number of subjects with treatment-related adverse events

Trial sites (3)

FacilityCityRegionStatus
University at Buffalo Neurosurgery (UBNS) Buffalo New York
Mount Sinai Health System New York New York
University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Other trials for the same condition

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A Study of Deramiocel (CAP-1002) in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy Active, not recruiting
Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury Recruiting
VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration Recruiting
LTFU Study of Subjects Who Received GRNOPC1 Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05035823 on ClinicalTrials.gov ↗ ← All trials in the USA