Status:
RECRUITING
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
Lead Sponsor:
Leigh R. Hochberg, MD, PhD.
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
US Department of Veterans Affairs
Conditions:
Tetraplegia
Spinal Cord Injuries
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment...
Eligibility Criteria
Inclusion
- 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
- 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 :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2038
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00912041
Start Date
May 1 2009
End Date
December 1 2038
Last Update
December 3 2025
Active Locations (5)
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1
University of California, Davis
Sacramento, California, United States, 95817
2
Stanford University School of Medicine
Stanford, California, United States, 94305
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114