Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Pittsburgh
Sponsor:
Collaborators:
Johns Hopkins University
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01364480
First received: May 25, 2011
Last updated: February 12, 2014
Last verified: February 2014

May 25, 2011
February 12, 2014
May 2011
November 2014   (final data collection date for primary outcome measure)
The primary outcome is the safety of the participant. [ Time Frame: One year following array implantation ] [ Designated as safety issue: Yes ]
This measure will be considered a success if the device is not removed for safety reasons during the 12-month post-implant evaluation.
Same as current
Complete list of historical versions of study NCT01364480 on ClinicalTrials.gov Archive Site
The secondary outcome is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices. [ Time Frame: One year following array implantation ] [ Designated as safety issue: No ]
The efficacy of the electrodes will be determined through a variety of measures, including characterization of signal quality, degrees of freedom achieved and subject performance.
Same as current
Not Provided
Not Provided
 
Microelectrode Brain-Machine Interface for Individuals With Tetraplegia
Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain activity.

Individuals with tetraplegia (paralysis caused by illness or injury that results in partial or total loss of use of the arms and legs) have intact brain function but are unable to move due to injury or disease affecting the spinal cord, nerves or muscles. Brain-machine interface (BMI) technology is based on the finding that with intact brain function, neural signals are generated even though they are not sent to the arms, hands and legs. By implanting electrodes in the brain, individuals can be trained to send neural signals which are interpreted by a computer and translated to movement which can then be used to control a variety of devices or computer displays.

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Tetraplegia
  • Spinal Cord Injury
Device: Implantation of NeuroPort Arrays in the motor cortex
Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.
Other Names:
  • neuroprosthetic
  • brain-machine interface
  • brain-computer interface
Experimental: Brain-Machine Interface Users
All participants enrolled in the study will be individuals implanted with microelectrodes in their brain to record neural activity. There is no control group.
Intervention: Device: Implantation of NeuroPort Arrays in the motor cortex
Collinger JL, Wodlinger B, Downey JE, Wang W, Tyler-Kabara EC, Weber DJ, McMorland AJ, Velliste M, Boninger ML, Schwartz AB. High-performance neuroprosthetic control by an individual with tetraplegia. Lancet. 2013 Feb 16;381(9866):557-64. doi: 10.1016/S0140-6736(12)61816-9. Epub 2012 Dec 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
Not Provided
November 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 or brainstem or spinal stroke
  • At least 1 year post-injury
  • Live within 1 hour of the University of Pittsburgh and be willing to travel to the University of Pittsburgh once per week for BMI training
  • 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
  • Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise
  • Additional exclusion criteria must also be reviewed
Both
18 Years to 70 Years
No
Contact: Debbie E Harrington, BS 412-383-1355 harringtond2@upmc.edu
United States
 
NCT01364480
PRO10080021
Yes
University of Pittsburgh
University of Pittsburgh
  • Department of Defense
  • Johns Hopkins University
Principal Investigator: Michael L Boninger, MD University of Pittsburgh
University of Pittsburgh
February 2014

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