Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

This study is currently recruiting participants.

See

Contacts and Locations

Verified February 2017 by Michael Boninger, University of Pittsburgh

Sponsor:

Collaborators:

United States 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: February 13, 2017

Last verified: February 2017

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:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Other
Official Title:	Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Further study details as provided by Michael Boninger, University of Pittsburgh:

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 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 ]
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 Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2017 (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 (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

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, see Learn About Clinical Studies.

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

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):

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.


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:	February 13, 2017
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

ClinicalTrials.gov processed this record on July 07, 2017

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