NCT02564419

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Jonathan Jagid · Academic / Other
• Sex: All
• Age: 22 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	Medtronic Activa PC+S	Upon consent, the good candidates will undergo surgical screening that includes a full neurological workup and baseline functional assessment. Subjects that demonstrate feasibility for control will undergo surgery for unilateral implantation of the Activa PC+S as well as the implantation of unilateral subdural strip electrodes (Resume II, model 3587A) over the motor cortex. After 24 hour observation in the hospital, subjects will participate in 24 distinct sessions or visits of testing over a 3-6 month period. During these visits, the sensing, decoding of the implanted device (Activa PC+S) as well as the external stimulation components (Bioness H200) and parameters will be tested and benchmarked. Subjects will participate for 24 sessions and continue to participate in the study until the end of life of the device, at which point the subject may elect to undergo an explant at that time.

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2015-09-30
• Last updated: 2020-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study