Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

December 15, 2023 updated by: Michael Boninger
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Successful Implant
Time Frame: One year following array implantation
Number of participants who were implanted for at least one year without having to explant the device for safety reasons.
One year following array implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7 Degree-of-freedom Movement by Neural Control
Time Frame: One year following array implantation
A modified Action Research Arm Test (ARAT) assessment for upper extremity performance was conducted to evaluate neural control of movement of a robotic prosthetic arm with 7 independent degrees of freedom controlled simultaneously. The degrees of freedom included: 3D translation of arm, 3D orientation of wrist, and 1D open/closing of hand. The participant used a brain-controlled robotic hand to do 9 tasks (out of 19). Each test item was timed and scored as 0 (no movement), 1 (task partly done), 2 (task done, but not correctly), or 3 (task done correctly). Movements that required more than 5 s to complete were scored as 2. The participant attempted each assessment three times and the best score was included. The total possible score ranged from 0 to 27 (i.e., max possible score of 3 each for 9 total tasks). A higher score indicates a better outcome.
One year following array implantation
10 Degree-of-freedom Movement by Neural Control
Time Frame: One year following array implantation
A modified ARAT was conducted to assess neural control of movement of a robotic prosthetic arm with 10 independent degrees of freedom, controlled simultaneously. Degrees of freedom included: 3D translation of arm, 3D orientation of wrist, and 4 degrees dictating hand shape, including pinch (flexion of thumb, index and middle fingers), scoop (flexion of ring and pinky fingers), finger abduction (of index, ring and little fingers), and thumb opposition. The participant used a brain-controlled robotic hand to do 9 tasks (out of 19). Test items were timed and scored as 0 (no movement), 1 (task partly done), 2 (task done, but not correctly), or 3 (task done correctly). Movements that required more than 5 s to complete were scored as 2. The participant attempted each assessment three times and the best score was included. The total possible score ranged from 0 to 27 (i.e., max possible score of 3 each for 9 total tasks). A higher score indicates a better outcome.
One year following array implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Boninger

Investigators

  • Principal Investigator: Michael L Boninger, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Actual)

November 26, 2022

Study Completion (Actual)

November 26, 2022

Study Registration Dates

First Submitted

May 25, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (Estimated)

June 2, 2011

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19030235

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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