Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

Completed · Not applicable

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT02564419

Run by

Jonathan Jagid

People needed

1

Starts

2015-11-01

Expected to finish

2019-11-30

Last updated by the study team

2020-09-18

Who can join

Age: 22 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Coagulopathy
• Anticoagulation
• Pregnancy

Where it is running

• University of Miami School of Medicine/Miami Project to Cure Paralysis — Miami, Florida, United States

Full record on ClinicalTrials.gov

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