ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Wei Wang, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01393444
First received: July 11, 2011
Last updated: May 19, 2014
Last verified: May 2014

July 11, 2011
May 19, 2014
May 2011
August 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01393444 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Same as current
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, such as tetraplegia due to spinal cord injury, 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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 be individuals implanted with an ECoG sensor on the surface of their brain to record neural activity. There is no control group.
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.
 
Recruiting
3
November 2014
August 2014   (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
Both
18 Years to 70 Years
No
Contact: Debbie Harrington 412-383-1355 harringtond2@upmc.edu
United States
 
NCT01393444
PRO10010149
Yes
Wei Wang, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Wei Wang, MD, PhD University of Pittsburgh
University of Pittsburgh
May 2014

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