Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface

Conditions
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Anarthria, Dysarthria, Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked-in Syndrome, Muscular Dystrophies

Intervention / Treatment
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* Device: BrainGate Neural Interface System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 (There are additional inclusion criteria) Exclusion Criteria: Between 18 and 80 years of age. The patient must be able to speak understandably or if unable to speak understandably must have one reliable means of communication. Complete or incomplete tetraplegia (quadriplegia) A minimum of twelve months elapsed post-injury and recovery must have plateaued at least 3 months prior to baseline screening. Per clinical opinion, a life expectancy of greater than 6 months. Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment. (There are additional exclusion criteria)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BrainGate Neural Interface System<br>Placement of the BrainGate2 sensor(s) into the speech-related cortex | Device: BrainGate Neural Interface System<br>* Placement of the BrainGate2 sensor(s) into the speech-related cortex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant | To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and: the sensors are not explanted for safety reasons during the one-year post-implant evaluation period. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decoded speech output accuracy | The purpose of this feasibility measure is to define the metrics by which a larger trial of intracortical recording for the restoration of speech-based communication might be planned. The secondary endpoints are: The word error rate of speech that is output by the System The phoneme error rate of speech that is output by the System | At participant exit from study, or up to 5 years |