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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
NCT05724173 · Massachusetts General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis
About this study
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, to recover a host of abilities that normally rely on the hands or on speech.
Eligibility criteria
Inclusion Criteria:
* Between 18 and 80 years of age.
* Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
* Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
* Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.
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)
Study design
Enrollment target: 3 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-18
Estimated completion: 2026-12
Last updated: 2025-12-03
Interventions
Device: BrainGate Neural Interface System
Primary outcomes
- • Device Safety (1 year)
Sponsor
Leigh R. Hochberg, MD, PhD. · other
With: National Institute on Deafness and Other Communication Disorders (NIDCD)
Contacts & investigators
ContactLeigh R Hochberg, MD, Ph.D · contact · lhochberg@mgh.harvard.edu · 617-724-9247
ContactJaimie Henderson, MD · contact · henderj@stanford.edu · 650-723-5574
InvestigatorJaimie Henderson, MD · principal_investigator, Stanford University
All locations (2)
Stanford University School of MedicineRecruiting
Stanford, California, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States