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

ID#: NCT05035823

Age: 21 - 75 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: April 27, 2022

End Date: June 01, 2024

Contact Information:
Marta Lapinska
646-689-1776
Melissa Ilnicki
412-864-0865
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.
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