Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Sponsor

Michael Boninger (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01364480

Collaborator

(none)

Enrollment

Location

Arm

163.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 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

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. [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. [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

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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