ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

Study Overview
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Brief Summary
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The purpose of this research study is to demonstrate that individuals with upper limb paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis and brain stem stroke can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain computer interface system.

Detailed Description
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Brain-computer interface (BCI) technology aims to establish a direct link for transmitting information between the brain and external devices, offering a natural and rich control signal for prosthetic hands or functional electrical stimulators (FES) to re-animate paralyzed hands. This study focuses on an ECoG-based BCI system. ECoG measures brain activity using electrodes implanted on the surface of the brain. Each participant will undergo testing of the ECoG direct brain interface for up to 29 days. Participants will learn to control computer cursors, virtual reality environments, and assistive devices such as hand orthoses and functional electrical stimulators using neural activity recorded with the ECoG sensor.

Official Title
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Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis

Conditions
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Tetraplegia, Spinal Cord Injury, Brachial Plexus Injury, Muscular Dystrophy, ALS, Brainstem Stroke

Intervention / Treatment
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* Device: Implantation of ECoG sensors on the brain surface


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, brachial plexus injury, brainstem stroke, muscular dystrophy, or amyotrophic lateral sclerosis (ALS) or other motor neuron diseases At least 1 year post-injury Live within 1 hour of the University of Pittsburgh or willing to stay in Pittsburgh while the ECoG electrode is implanted (up to 29 days) 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 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct Brain Interface Users<br>All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms. | Device: Implantation of ECoG sensors on the brain surface<br>* One ECoG sensor will be implanted over the motor cortex of study participants<br>* Other names: neuroprosthetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG | Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG. | Up to 29 days of device implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System | Participants will be asked to perform, attempt, or imagine performing motor tasks while their brain activity is recorded in order to observe the changes in neural activity during each task. | Up to 29 days of device implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrocorticography, Tetraplegia, Spinal cord injury, Brainstem stroke, Neuroprosthetic, Brain-computer interface, Direct brain interface, Neural activity, Motor cortex