TrialPath
Recruiting

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: 2027-07-31
Last updated: 2026-06-02
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