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ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01393444
First Posted: July 13, 2011
Last Update Posted: December 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jennifer Collinger, PhD, University of Pittsburgh
July 11, 2011
July 13, 2011
August 17, 2016
December 12, 2016
December 12, 2016
May 2011
April 2015   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01393444 on ClinicalTrials.gov Archive Site
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.
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.
Not Provided
Not Provided
 
ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis
Acute Electrocorticography (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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
  • Tetraplegia
  • Spinal Cord Injury
  • Brachial Plexus Injury
  • Muscular Dystrophy
  • ALS
  • Brainstem Stroke
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
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.
Intervention: Device: Implantation of ECoG sensors on the brain surface
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01393444
PRO10010149
Yes
Not Provided
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.
Jennifer Collinger, PhD, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Jennifer L Collinger, PhD University of Pittsburgh
University of Pittsburgh
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP