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

N/AActive Not RecruitingNCT05035823

Synchron Medical, Inc.6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Neurologic Disorder Paralysis Paralysis; Stroke Amyotrophic Lateral Sclerosis Muscular Dystrophies

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

University at Buffalo Neurosurgery (UBNS)

Buffalo, New York, United States

Mount Sinai Health System

New York, New York, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Treatment-Related Serious Adverse Events

Number of subjects with treatment-related adverse events

Time frame: 12 months post implant