Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

NACompletedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

November 30, 2019

Study Completion Date

November 30, 2019

Conditions
Spinal Cord Injury
Interventions
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.

Trial Locations (1)

33136

University of Miami School of Medicine/Miami Project to Cure Paralysis, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

lead

Jonathan Jagid

OTHER