Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

Early Feasibility Study of a Medtronic Activa PC+S System for Persons Living With Spinal Cord Injury

In this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex. These electrodes implanted in the brain will enable bioelectrical data recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data will be

1. either processed in the Activa PC+S; or
2. off-loaded via the Nexus D communication device (Medtronic) to a computer.

Inclusion Criteria:

• AIS Grades A & B
• Level of Injury C5 or C6
• Local Community dwelling
• Stable chronic injury
• Stable health status and upper extremities
• Completion of Clinical Protocol 01

Exclusion Criteria:

• Coagulopathy
• Anticoagulation
• Pregnancy