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

Trial ID: NCT00912041

Interventional - Phase Unknown - Recruiting

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.

Conditions

• Tetraplegia
• Spinal Cord Injuries
• Amyotrophic Lateral Sclerosis
• Brain Stem Infarctions
• Locked in Syndrome
• Muscular Dystrophy

Interventions

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

Eligibility

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)

Sponsor

Leigh R. Hochberg, MD, PhD., National Institute on Deafness and Other Communication Disorders (NIDCD), US Department of Veterans Affairs, National Institute of Neurological Disorders and Stroke (NINDS)

Source: ClinicalTrials.gov

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