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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. Read our disclaimer for details. Identifier: NCT01364480
Recruitment Status : Active, not recruiting
First Posted : June 2, 2011
Last Update Posted : March 8, 2022
Information provided by (Responsible Party):
Michael Boninger, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tetraplegia Spinal Cord Injury Device: Implantation of NeuroPort Arrays in the motor cortex Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Microelectrode Brain-Machine Interface for Individuals With Tetraplegia
Actual Study Start Date : May 1, 2011
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
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.
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

Primary Outcome Measures :
  1. 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 post-implant evaluation.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01364480

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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Michael Boninger
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Principal Investigator: Michael L Boninger, MD University of Pittsburgh
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Michael Boninger, Vice Chair of Research, University of Pittsburgh Identifier: NCT01364480    
Other Study ID Numbers: STUDY19030235
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We may share de-identified data with collaborators.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Minimum of seven years after final reporting or publication
Access Criteria: Researchers interested in this topic at the University of Pittsburgh, the University of Chicago, and other centers
Keywords provided by Michael Boninger, University of Pittsburgh:
Spinal cord injury
Brainstem or spinal stroke
Brain-machine interface
Brain-computer interface
Neural activity
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations