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 ALSStudy Type:
Interventional TrialStudy Category:
DeviceStudy Status:
EnrollingPhase:
Not ApplicableStudy Chair(s)/Principal Investigator(s):
Leigh R Hochberg, M.D., Ph.D (Massachusetts General Hospital)
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 Institute on Deafness and Other Communication Disorders (NIDCD), VA Office of Research and Development, National Institute of Neurological Disorders and Stroke (NINDS)Participant Duration:
approximately 13 months