BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility of efficacy) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS, Primary Lateral Sclerosis (PLS), Hereditary Spastic Paraplegia (HSP)
Study Type:Interventional Trial
Study Chair(s)/Principal Investigator(s):
Leigh R Hochberg, M.D., Ph.D (Massachusetts General Hospital)
Sydney S Cash, M.D., Ph.D. (MGH)
Merit E Cudkowicz, M.D., M.Sc. (MGH)
Emad Eskandar, M.D. (MGH)
Clinicaltrials.gov ID (11 digit #):NCT00912041
Coordinating Center Contact InformationMassachusetts General Hospital
Full Study Summary:
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 to recover a host of abilities that normally rely on the hands.
The 4x4 mm BrainGate2 sensor is placed into the motor cortex, connected to a percutaneous pedestal. Neural recordings are made at least weekly for a year or more.
Study Sponsor:National Center for Medical Rehabilitation Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Deafness and Other Communication Disorders (NIDCD), Department of Veterans Affairs
approximately 13 months
Estimated Study Start Date:04/30/2009
Estimated Study Completion Date:11/30/2017
Posting Last Modified Date:05/31/2014
Date Study Added to alsconsortium.org:11/03/2011
This study is invasive and requires surgery. You must live within 3 hours of Boston, Massachusetts, Providence, RI, Palo Alto, California or Cleveland, Ohio to participate.
Time since Symptom Onset:
Time since Diagnosis:
Can participants use Riluzole?
•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)
•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)
Site Contact Information
Stanford University School of Medicine
Stanford, California 94305
Massachusetts General Hospital
Boston, Massachusetts 02114
Case Western Reserve University
Veterans Affairs Hospital
Providence, Rhode Island 02908