Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-01

Study Completion Date

2022-11-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tetraplegia Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Implantation of NeuroPort Arrays in the motor cortex

Intervention Type DEVICE

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

Interventions

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Implantation of NeuroPort Arrays in the motor cortex

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

Intervention Type DEVICE

Other Intervention Names

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neuroprosthetic brain-machine interface brain-computer interface

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No