BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
Study Purpose:
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 TrialStudy Category:
DeviceStudy Status:
Active, currently recruitingPhase:
Not ApplicableStudy Chair(s)/Principal Investigator(s):
Leigh R Hochberg, M.D., Ph.D (Massachusetts General Hospital)
Sub Investigators:
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 #):
NCT00912041Neals Affiliated?
NoCoordinating Center Contact Information
Massachusetts General HospitalLeigh R Hochberg, M.D., Ph.D. / .(JavaScript must be enabled to view this email address) / 617-724-9247
.(JavaScript must be enabled to view this email address) Boston, Massachusetts 02114 United States
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 AffairsParticipant Duration:
approximately 13 months