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.


Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:


Study Status:



Not Applicable

Study Chair(s)/Principal Investigator(s):

Leigh R Hochberg, M.D., Ph.D (Massachusetts General Hospital) ID (11 digit #):


Neals Affiliated?


Coordinating Center Contact Information

Massachusetts General Hospital
Leigh 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

Estimated Enrollment:


Estimated Study Start Date:


Estimated Study Completion Date:


Posting Last Modified Date:


Date Study Added to

  • More Information

    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.

  • Eligibility Criteria


    Female, Male

    Minimum Age:


    Maximum Age:


    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    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)

  • Site Contact Information

    Stanford University School of Medicine
    Jaimie Henderson, M.D. / .(JavaScript must be enabled to view this email address) / 650-723-5574
    Stanford, California 94305
    United States

    Massachusetts General Hospital
    Leigh R Hochberg, M.D., Ph.D. / .(JavaScript must be enabled to view this email address) / 617-742-9247
    Boston, Massachusetts 02114
    United States

    Providence VA Medical Center
    Stephen Mernoff, M.D. / .(JavaScript must be enabled to view this email address) / 401-273-7100
    Providence, Rhode Island 02908
    United States