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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.
 
ClinicalTrials.gov Identifier: NCT01364480
Recruitment Status : Active, not recruiting
First Posted : June 2, 2011
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Boninger, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE May 25, 2011
First Posted Date  ICMJE June 2, 2011
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE May 1, 2011
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microelectrode Brain-Machine Interface for Individuals With Tetraplegia
Official Title  ICMJE Microelectrode Brain-Machine Interface for Individuals With Tetraplegia
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Tetraplegia
  • Spinal Cord Injury
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2011)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01364480
Other Study ID Numbers  ICMJE STUDY19030235
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We may share de-identified data with collaborators.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party Michael Boninger, University of Pittsburgh
Study Sponsor  ICMJE Michael Boninger
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael L Boninger, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date April 2021

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