Actively Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
Led by Leigh R. Hochberg, MD, PhD. · Updated on 2025-12-03
3
Participants Needed
2
Research Sites
162 weeks
Total Duration
On this page
Sponsors
L
Leigh R. Hochberg, MD, PhD.
Lead Sponsor
N
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 80 years of age.
- Diagnosis of amyotrophic lateral sclerosis (ALS) confirmed by a neurologic expert.
- Severe speech impairment with anarthria or severe dysarthria showing decline in the last four months.
- Living within a three-hour drive of the study site and able to remain geographically stable for at least 15 months after enrollment.
You will not qualify if you...
- Visual impairment that makes viewing a computer monitor difficult, even with corrective lenses.
- Use of chronic oral or intravenous steroids or immunosuppressive therapy.
- Presence of other serious diseases or disorders that could severely affect participation.
- Additional exclusion criteria not specified here.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Stanford University School of Medicine
Stanford, California, United States, 94305
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Leigh R Hochberg, MD, Ph.D
CONTACT
J
Jaimie Henderson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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