RECRUITINGINTERVENTIONAL
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
About This Trial
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
Who May Be Eligible (Plain English)
Who May Qualify:
- Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
- Complete or incomplete tetraplegia (quadriplegia)
- Must live within a three-hour drive of the Study site
- (There are additional inclusion criteria)
Who Should NOT Join This Trial:
- Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
- Chronic oral or intravenous steroids or immunosuppressive therapy
- Other serious disease or disorder that could seriously affect ability to participate in the study
- (There are additional exclusion criteria)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
* Complete or incomplete tetraplegia (quadriplegia)
* Must live within a three-hour drive of the Study site
* (There are additional inclusion criteria)
Exclusion Criteria:
* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
* Chronic oral or intravenous steroids or immunosuppressive therapy
* Other serious disease or disorder that could seriously affect ability to participate in the study
* (There are additional exclusion criteria)
Treatments Being Tested
DEVICE
Placement of the BrainGate2 sensor(s) into the motor-related cortex
Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
Locations (5)
University of California, Davis
Sacramento, California, United States
Stanford University School of Medicine
Stanford, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Providence VA Medical Center
Providence, Rhode Island, United States