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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. 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
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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
Tetraplegia Spinal Cord Injury Device: Implantation of NeuroPort Arrays in the motor cortex

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Microelectrode Brain-Machine Interface for Individuals With Tetraplegia
Study Start Date : May 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020
Arms and Interventions

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


Outcome Measures

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 12-month 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01364480


Contacts
Contact: Debbie E Harrington, BS 412-383-1355 harringtond2@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Debbie E Harrington, BS    412-383-1355    harringtond2@upmc.edu   
Principal Investigator: Michael L Boninger, MD         
Sponsors and Collaborators
Michael Boninger
United States Department of Defense
Johns Hopkins University
Investigators
Principal Investigator: Michael L Boninger, MD University of Pittsburgh
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Boninger, Professor and Chair of Physical Medicine & Rehabilitation, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01364480     History of Changes
Other Study ID Numbers: PRO10080021
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: January 15, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We may share de-identified data with collaborators.

Keywords provided by Michael Boninger, University of Pittsburgh:
Tetraplegia
Spinal cord injury
Brainstem or spinal stroke
Neuroprosthetic
Brain-machine interface
Brain-computer interface
Neural activity

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms