Status:
RECRUITING
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Lead Sponsor:
Leigh R. Hochberg, MD, PhD.
Collaborating Sponsors:
Brown University
Stanford University
Conditions:
Brainstem Stroke
ALS
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In ...
Detailed Description
The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an i...
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
- Prior enrollment in BrainGate2 clinical trial (NCT00912041)
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 :
July 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2027
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06511934
Start Date
July 22 2024
End Date
July 30 2027
Last Update
December 1 2025
Active Locations (1)
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1
Masssachusetts General Hospital
Boston, Massachusetts, United States, 02114