Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis

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: 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. 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 |
| --- | --- |
| Other: 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 |
| --- | --- | --- |
| Device Safety | 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 |
| --- | --- | --- |
| Device Feasibility | 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: Number of participants that are able to use the BrainGate system to communicate via speech decoding: at a rate of at least 5 words per minute and with less than a median word error rate of 50%. | At participant exit from study, or up to 5 years |