Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Study Overview
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Brief Summary
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The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain activity.

Detailed Description
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Individuals with tetraplegia (paralysis caused by illness or injury that results in partial or total loss of use of the arms and legs) have intact brain function but are unable to move due to injury or disease affecting the spinal cord, nerves or muscles. Brain-machine interface (BMI) technology is based on the finding that with intact brain function, neural signals are generated even though they are not sent to the arms, hands and legs. By implanting electrodes in the brain, individuals can be trained to send neural signals which are interpreted by a computer and translated to movement which can then be used to control a variety of devices or computer displays.

Official Title
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Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Conditions
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Tetraplegia, Spinal Cord Injury

Intervention / Treatment
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* Device: Implantation of NeuroPort Arrays in the motor cortex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Limited or no ability to use both hands due to cervical spinal cord injury or brainstem or spinal stroke At least 1 year post-injury Live within 1 hour of the University of Pittsburgh and be willing to travel to the University of Pittsburgh once per week for BMI training Additional inclusion criteria must also be reviewed Exclusion Criteria: Certain implanted devices Presence of other serious disease or disorder that could affect ability to participate in this study Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise Additional exclusion criteria must also be reviewed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Brain-Machine Interface Users<br>All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group. | Device: Implantation of NeuroPort Arrays in the motor cortex<br>* Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.<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 outcome is the safety of the participant. | This measure will be considered a success if the device is not removed for safety reasons during the post-implant evaluation. | One year following array implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices. | The efficacy of the electrodes will be determined through a variety of measures, including characterization of signal quality, degrees of freedom achieved and subject performance. | One year following array implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tetraplegia, Spinal cord injury, Brainstem or spinal stroke, Neuroprosthetic, Brain-machine interface, Brain-computer interface, Neural activity