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Completed

NCT Number: NCT01393444

ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

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.

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Key information

Conditions

Tetraplegia ALS Brachial Plexus Injury Brain Diseases Brain Infarction Brain Ischemia Brain Stem Infarctions Brainstem Stroke Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Infarction Ischemia Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy Musculoskeletal Diseases Necrosis Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of ECoG sensors on the brain surface

Device

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

Other names: brain-computer interface, neuroprosthetic

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2011
Registry last updated
Dec 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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