RecruitingNot ApplicableNCT00912041

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia


Sponsor

Leigh R. Hochberg, MD, PhD.

Enrollment

27 participants

Start Date

May 1, 2009

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

BrainGate2 is a research study testing a small sensor implanted in the brain that can detect brain signals and translate them into computer or device commands. The goal is to help people with severe paralysis — such as those with spinal cord injuries, ALS, or stroke — regain the ability to communicate and control devices using their thoughts. You may be eligible if: - You are between 18 and 80 years old - You have a diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, ALS, or another motor neuron disorder - You have complete or incomplete tetraplegia (paralysis in all four limbs) - You live within a three-hour drive of the study site You may NOT be eligible if: - You have significant vision problems that can't be corrected with glasses - You are on chronic oral or intravenous steroids or immunosuppressive medication - You have another serious illness that would interfere with your ability to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPlacement of the BrainGate2 sensor(s) into the motor-related cortex

Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.


Locations(5)

University of California, Davis

Sacramento, California, United States

Stanford University School of Medicine

Stanford, California, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Providence VA Medical Center

Providence, Rhode Island, United States

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NCT00912041


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