Trials / Active Not Recruiting
Active Not RecruitingNCT05035823
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Synchron Medical, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Motor Neuroprosthesis (MNP) | Type of implantable brain computer interface |
Timeline
- Start date
- 2022-04-27
- Primary completion
- 2024-09-19
- Completion
- 2026-09-01
- First posted
- 2021-09-05
- Last updated
- 2025-04-29
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05035823. Inclusion in this directory is not an endorsement.