We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01364480
Recruitment Status : Recruiting
First Posted : June 2, 2011
Last Update Posted : January 15, 2018
Information provided by (Responsible Party):

May 25, 2011
June 2, 2011
January 15, 2018
May 2011
December 2018   (Final data collection date for primary outcome measure)
The primary outcome is the safety of the participant. [ Time Frame: One year following array implantation ]
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 ]
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.
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • 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 undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group.
Intervention: Device: Implantation of NeuroPort Arrays in the motor cortex

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2020
December 2018   (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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact: Debbie E Harrington, BS 412-383-1355 harringtond2@upmc.edu
United States
Not Provided
Plan to Share IPD: Yes
Plan Description: We may share de-identified data with collaborators.
Michael Boninger, University of Pittsburgh
Michael Boninger
  • United States Department of Defense
  • Johns Hopkins University
Principal Investigator: Michael L Boninger, MD University of Pittsburgh
University of Pittsburgh
January 2018

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