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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05035823
Enrollment
6
Registered
2021-09-05
Start date
2022-04-27
Completion date
2028-09-01
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis, Cervical Spinal Cord Injury, Muscular Dystrophies, Neurologic Disorder, Paralysis, Paralysis; Stroke, Quadriplegia/Tetraplegia, Spinal Cord Injuries, Spinal Muscular Atrophy, Stroke Brainstem, Stroke, Lacunar, Tetraplegic; Paralysis

Brief 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.

Interventions

DEVICEMotor Neuroprosthesis (MNP)

Type of implantable brain computer interface

Sponsors

Synchron Medical, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Treatment-Related Serious Adverse Events12 months post implantNumber of subjects with treatment-related adverse events

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026