Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
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 →
Unsure about the terms? Read our patient guide →
Official title
Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface
Overview
The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.
Detailed description
The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interface". The implanted medical device measures the person's brain activity as they try to talk and outputs their intended speech. By bypassing the injured parts of the nervous system this way, we can observe how individual brain cells are involved in speaking and working together as a network, to produce speech, and we can learn to decipher this activity to output what the person is trying to say.
Interventions
- Device BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into the speech-related cortex
Primary outcome measures
- Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant [Time frame: 1 year]
Secondary outcome measures (1)
- Decoded speech output accuracy [Time frame: At participant exit from study, or up to 5 years]
Eligibility criteria
Inclusion criteria
- Between 18 and 80 years of age
- Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
- Complete or incomplete tetraplegia (quadriplegia)
- Must live within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.
(There are additional inclusion criteria)
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 · 1 center
- University of California, Davis — Sacramento
Identifiers
NCT: NCT06094205 · 2009p000505 (BG-Speech-02) · 1DP2DC021055