ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

University of Pittsburgh6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

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

Interventions

Implantation of ECoG sensors on the brain surfaceDEVICE

One ECoG sensor will be implanted over the motor cortex of study participants

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 29 days of device implantation

Secondary Outcomes

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.

Time frame: Up to 29 days of device implantation

Data from ClinicalTrials.gov

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