Clinical Trial: ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: University of Pittsburgh

Current Primary Outcome: Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG [ Time Frame: Up to 29 days of device implantation ]

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.


Original Primary Outcome: The primary outcome is the successful control of a variety of external devices using neural data recorded with ECoG. [ Time Frame: Up to 29 days of device implantation ]

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.


Current Secondary Outcome: Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System [ Time Frame: Up to 29 days of device implantation ]

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.


Original Secondary Outcome: A secondary outcome is to demonstrate that individuals with upper limb paralysis can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain-computer interface system. [ Time Frame: Up to 29 days of device implantation ]

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.


Information By: University of Pittsburgh

Dates:
Date Received: July 11, 2011
Date Started: May 2011
Date Completion:
Last Updated: October 18, 2016
Last Verified: October 2016