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 Trial

Study Category:

Device

Study Status:

Active, currently recruiting

Phase:

Not Applicable

Study 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 #):

NCT00912041

Neals Affiliated?

No

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 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

Participant Duration:

approximately 13 months

Estimated Enrollment:

15

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
  • 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

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    75

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    Criteria
    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) / 617-726-4218
    Boston, Massachusetts 02114
    United States

    Case Western Reserve University
    Benjamin Walter, M.D. / .(JavaScript must be enabled to view this email address) / 216-844-8925
    Cleveland, Ohio
    United States

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