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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05035823
• Other study ID #: S-02-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Synchron, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Cervical Spinal Cord Injury
• Motor Neuron Disease
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Muscular Dystrophies
• Nervous System Diseases
• Neurologic Disorder
• Paralysis
• Quadriplegia
• Quadriplegia/Tetraplegia
• Spinal Cord Injuries
• Spinal Muscular Atrophy
• Stroke
• Stroke, Lacunar
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Synchron Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-Related Serious Adverse Events	Number of subjects with treatment-related adverse events	12 months post implant