COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
NCT05035823 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2025-04-29
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.
Conditions
- Neurologic Disorder
- Paralysis
- Paralysis; Stroke
- Amyotrophic Lateral Sclerosis
- Muscular Dystrophies
- Spinal Cord Injuries
- Stroke, Lacunar
- Stroke Brainstem
- Cervical Spinal Cord Injury
- Spinal Muscular Atrophy
- Tetraplegic; Paralysis
- Quadriplegia/Tetraplegia
Interventions
- DEVICE
-
Motor Neuroprosthesis (MNP)
Type of implantable brain computer interface
Sponsors & Collaborators
-
Synchron Medical, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-27
- Primary Completion
- 2024-09-19
- Completion
- 2026-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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