Status:
RECRUITING
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
Lead Sponsor:
Leigh R. Hochberg, MD, PhD.
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Anarthria
Dysarthria
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 w...
Detailed Description
The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interfa...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06094205
Start Date
October 16 2023
End Date
August 31 2027
Last Update
December 1 2025
Active Locations (1)
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1
University of California, Davis
Sacramento, California, United States, 95817