RECRUITINGINTERVENTIONAL
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface
About This Trial
The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.
Who May Be Eligible (Plain English)
Who May Qualify:
- Between 18 and 80 years of age
- 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 and geographically stable for at least 15 months after enrollment.
(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:
* Between 18 and 80 years of age
* 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 and geographically stable for at least 15 months after enrollment.
(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
BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into the speech-related cortex
Locations (1)
University of California, Davis
Sacramento, California, United States