Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BrainGate Neural Interface System.
- Who it may be relevant to
- Registry conditions: Anarthria, Dysarthria, Tetraplegia, Spinal Cord Injuries. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis
Overview
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.
Detailed description
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.
Interventions
- Device BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into the speech-related cortex
Primary outcome measures
- Device Safety [Time frame: 1 year]
Secondary outcome measures (1)
- Device Feasibility [Time frame: At participant exit from study, or up to 5 years]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Stanford University School of Medicine — Stanford
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT05724173 · 2022p003220 (BG-Speech-01) · U01DC019430