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Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Primary Purpose

Tetraplegia, Spinal Cord Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Implantation of NeuroPort Arrays in the motor cortex

About this trial

This is an interventional other trial for Tetraplegia focused on measuring Tetraplegia, Spinal cord injury, Brainstem or spinal stroke, Neuroprosthetic, Brain-machine interface, Brain-computer interface, Neural activity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain-Machine Interface Users

Arm Description

All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group.

Outcomes

Primary Outcome Measures

The primary outcome is the safety of the participant.

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.

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.

Full Information

NCT ID

NCT01364480

First Posted

May 25, 2011

Last Updated

March 3, 2023

Sponsor

Michael Boninger

1. Study Identification

Unique Protocol Identification Number

NCT01364480

Brief Title

Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Official Title

Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

May 1, 2011 (Actual)

Primary Completion Date

November 26, 2022 (Actual)

Study Completion Date

November 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael Boninger

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tetraplegia, Spinal Cord Injury

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brain-Machine Interface Users

Arm Type

Experimental

Arm Description

All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group.

Intervention Type

Device

Intervention Name(s)

Implantation of NeuroPort Arrays in the motor cortex

Other Intervention Name(s)

neuroprosthetic, brain-machine interface, brain-computer interface

Intervention Description

Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.

Primary Outcome Measure Information:

Title

The primary outcome is the safety of the participant.

Description

This measure will be considered a success if the device is not removed for safety reasons during the post-implant evaluation.

Time Frame

One year following array implantation

Secondary Outcome Measure Information:

Title

The secondary outcome is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices.

Description

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.

Time Frame

One year following array implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael L Boninger, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We may share de-identified data with collaborators.

IPD Sharing Time Frame

Minimum of seven years after final reporting or publication

IPD Sharing Access Criteria

Researchers interested in this topic at the University of Pittsburgh, the University of Chicago, and other centers

Citations:

PubMed Identifier

34847547

Citation

Sponheim C, Papadourakis V, Collinger JL, Downey J, Weiss J, Pentousi L, Elliott K, Hatsopoulos NG. Longevity and reliability of chronic unit recordings using the Utah, intracortical multi-electrode arrays. J Neural Eng. 2021 Dec 28;18(6):10.1088/1741-2552/ac3eaf. doi: 10.1088/1741-2552/ac3eaf.

Results Reference

derived

PubMed Identifier

32494819

Citation

Downey JE, Quick KM, Schwed N, Weiss JM, Wittenberg GF, Boninger ML, Collinger JL. The Motor Cortex Has Independent Representations for Ipsilateral and Contralateral Arm Movements But Correlated Representations for Grasping. Cereb Cortex. 2020 Sep 3;30(10):5400-5409. doi: 10.1093/cercor/bhaa120.

Results Reference

derived

PubMed Identifier

29553484

Citation

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.

Results Reference

derived

PubMed Identifier

29209023

Citation

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.

Results Reference

derived

PubMed Identifier

26987662

Citation

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.

Results Reference

derived

PubMed Identifier

25514320

Citation

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.

Results Reference

derived

PubMed Identifier

23253623

Citation

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.

Results Reference

derived

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Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

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