Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

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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

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	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.

Study Design

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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

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 :

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 :

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, Older Adult)
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

Locations

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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Michael Boninger

Investigators

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Principal Investigator:	Michael L Boninger, MD	University of Pittsburgh

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Downey JE, Schwed N, Chase SM, Schwartz AB, Collinger JL. Intracortical recording stability in human brain-computer interface users. J Neural Eng. 2018 Aug;15(4):046016. doi: 10.1088/1741-2552/aab7a0. Epub 2018 Mar 19.

Downey JE, Brane L, Gaunt RA, Tyler-Kabara EC, Boninger ML, Collinger JL. Motor cortical activity changes during neuroprosthetic-controlled object interaction. Sci Rep. 2017 Dec 5;7(1):16947. doi: 10.1038/s41598-017-17222-3.

Downey JE, Weiss JM, Muelling K, Venkatraman A, Valois JS, Hebert M, Bagnell JA, Schwartz AB, Collinger JL. Blending of brain-machine interface and vision-guided autonomous robotics improves neuroprosthetic arm performance during grasping. J Neuroeng Rehabil. 2016 Mar 18;13:28. doi: 10.1186/s12984-016-0134-9.

Wodlinger B, Downey JE, Tyler-Kabara EC, Schwartz AB, Boninger ML, Collinger JL. Ten-dimensional anthropomorphic arm control in a human brain-machine interface: difficulties, solutions, and limitations. J Neural Eng. 2015 Feb;12(1):016011. doi: 10.1088/1741-2560/12/1/016011. Epub 2014 Dec 16.

Collinger JL, Wodlinger B, Downey JE, Wang W, Tyler-Kabara EC, Weber DJ, McMorland AJ, Velliste M, Boninger ML, Schwartz AB. High-performance neuroprosthetic control by an individual with tetraplegia. Lancet. 2013 Feb 16;381(9866):557-64. doi: 10.1016/S0140-6736(12)61816-9. Epub 2012 Dec 17.

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Responsible Party:	Michael Boninger, Vice Chair of Research, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01364480
Other Study ID Numbers:	STUDY19030235
First Posted:	June 2, 2011 Key Record Dates
Last Update Posted:	April 14, 2021
Last Verified:	April 2021
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:


Tetraplegia Spinal cord injury Brainstem or spinal stroke Neuroprosthetic	Brain-machine interface Brain-computer interface Neural activity

Additional relevant MeSH terms:

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Spinal Cord Injuries Quadriplegia Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases	Trauma, Nervous System Wounds and Injuries Paralysis Neurologic Manifestations

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