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Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

This study is currently recruiting participants.
Verified March 2013 by University of Pittsburgh
Sponsor:
Collaborators:
Department of Defense
Johns Hopkins University
Information provided by (Responsible Party):
Michael Boninger, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01364480
First received: May 25, 2011
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 5
Study Start Date: May 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Pittsburgh
Department of Defense
Johns Hopkins University
Investigators
Principal Investigator: Michael L Boninger, MD University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional 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
Study First Received: May 25, 2011
Last Updated: March 12, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2013