RECRUITINGINTERVENTIONAL
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis
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:
- Between 18 and 80 years of age.
- Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
- Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
- Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.
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:
* Between 18 and 80 years of age.
* Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
* Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
* Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.
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
BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into the speech-related cortex
Locations (2)
Stanford University School of Medicine
Stanford, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States