ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

Not Applicable

Completed

• Conditions: Brainstem Stroke; Tetraplegia; Brachial Plexus Injury; Spinal Cord Injury; ALS; Muscular Dystrophy
• Interventions: Device: Implantation of ECoG sensors on the brain surface

• Registration Number: NCT01393444
• Lead Sponsor: University of Pittsburgh

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 Description

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-13
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2016-08-17
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-18
• Last Update Submitted: 2016-10-18
• Results First Posted: 2016-12-12
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Direct Brain Interface Users	Implantation of ECoG sensors on the brain surface	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States