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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

NCT05724173 · Massachusetts General Hospital
In plain English

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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
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia · TrialPath