BrainGate2: Feasibility Study of an Intracortical Neural Interface System for 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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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

Conditions
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Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked in Syndrome, Muscular Dystrophy

Intervention / Treatment
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* Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex


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: 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)

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<br>BrainGate Neural Interface System | Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex<br>* Up to four 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one or two percutaneous pedestals. Neural recordings are made at least weekly for a year or more.<br>* Other names: brain-computer interface;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System. |  | One year post-implant evaluation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints. |  | Course of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain computer interface, Assistive device, Environmental control, Communication device, quadriplegia, tetraplegia