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ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

This study has been completed.
Information provided by (Responsible Party):
Jennifer Collinger, PhD, University of Pittsburgh Identifier:
First received: July 11, 2011
Last updated: October 18, 2016
Last verified: October 2016
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.

Condition Intervention
Spinal Cord Injury
Brachial Plexus Injury
Muscular Dystrophy
Brainstem Stroke
Device: Implantation of ECoG sensors on the brain surface

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 6
Study Start Date: May 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Direct Brain Interface Users
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
One ECoG sensor will be implanted over the motor cortex of study participants
Other Names:
  • brain-computer interface
  • neuroprosthetic

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01393444

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Jennifer L Collinger, PhD University of Pittsburgh
  More Information

Additional Information:
Responsible Party: Jennifer Collinger, PhD, Assistant Professor, University of Pittsburgh Identifier: NCT01393444     History of Changes
Other Study ID Numbers: PRO10010149
Study First Received: July 11, 2011
Results First Received: August 17, 2016
Last Updated: October 18, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Study sponsors, as well as the FDA, will have access to research data and documents in order to monitor the integrity of the study.

Keywords provided by University of Pittsburgh:
Spinal cord injury
Brainstem stroke
Brain-computer interface
Direct brain interface
Neural activity
Motor cortex

Additional relevant MeSH terms:
Spinal Cord Injuries
Brain Stem Infarctions
Spinal Cord Diseases
Brain Infarction
Wounds and Injuries
Muscular Dystrophies
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn
Neurologic Manifestations
Signs and Symptoms
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on May 24, 2017