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NCT00912041NARecruiting

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

Leigh R. Hochberg, MD, PhD.

Start Date

5/1/2009

Completion Date

12/1/2038

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.

Detailed Description

The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: * Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders * Complete or incomplete tetraplegia (quadriplegia) * Must live within a three-hour drive of the Study site * (There are additional inclusion criteria) Exclusion Criteria: * Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses * Chronic oral or intravenous steroids or immunosuppressive therapy * Other serious disease or disorder that could seriously affect ability to participate in the study * (There are additional exclusion criteria)

Interventions

DEVICE

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

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Conditions

TetraplegiaSpinal Cord InjuriesAmyotrophic Lateral SclerosisBrain Stem InfarctionsLocked in SyndromeMuscular Dystrophy

Locations

University of California, Davis

Sacramento, California 95817

United States

Stanford University School of Medicine

Stanford, California 94305

United States

Emory University School of Medicine

Atlanta, Georgia 30322

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Providence VA Medical Center

Providence, Rhode Island 02908

United States

Baylor College of Medicine

Houston, Texas 77030

United States