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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia (BrainGate2)

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ClinicalTrials.gov Identifier: NCT00912041
Recruitment Status : Recruiting
First Posted : June 3, 2009
Last Update Posted : September 14, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Tetraplegia Spinal Cord Injuries Amyotrophic Lateral Sclerosis Brain Stem Infarctions Locked in Syndrome Muscular Dystrophy Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
Study Start Date : May 2009
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Arms and Interventions

Arm Intervention/treatment
BrainGate Neural Interface System
Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex
One or two 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex, connected to a percutaneous pedestal. Neural recordings are made at least weekly for a year or more.
Other Names:
  • BrainGate
  • NeuroPort
  • neural prosthesis
  • neural prosthetic
  • neuroprosthetic
  • brain computer interface
  • brain-computer interface

Outcome Measures

Primary Outcome Measures :
  1. The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System. [ Time Frame: One year post-implant evaluation period ]

Secondary Outcome Measures :
  1. To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints. [ Time Frame: Course of the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912041

Contact: Leigh R Hochberg, M.D., Ph.D. 617-724-9247 clinicaltrials@braingate.org

United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Jaimie Henderson, M.D.    650-723-5574    henderj@stanford.edu   
Principal Investigator: Jaimie Henderson, M.D.         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Leigh R Hochberg, M.D., Ph.D.         
Sub-Investigator: Sydney S Cash, M.D., Ph.D.         
Sub-Investigator: Merit E Cudkowicz, M.D., M.Sc.         
Sub-Investigator: Emad Eskandar, M.D.         
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Benjamin Walter, MD    216-844-8285    Benjamin.Walter@uhhospitals.org   
Contact: Bolu Ajiboye, PhD    216-368-6814    bolu.ajiboye@case.edu   
Principal Investigator: Benjamin Walter, MD         
Sub-Investigator: Jonathan Miller, MD         
Sub-Investigator: Robert Kirsch, PhD         
United States, Rhode Island
Providence VA Medical Center Recruiting
Providence, Rhode Island, United States, 02908
Contact: Stephen Mernoff, M.D.       stephen.mernoff@va.gov   
Principal Investigator: Stephen Mernoff, M.D.         
Sub-Investigator: Leigh R Hochberg, M.D., Ph.D.         
Sponsors and Collaborators
Leigh R. Hochberg, MD, PhD.
National Center for Medical Rehabilitation Research (NCMRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
VA Office of Research and Development
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Leigh R Hochberg, M.D., PH.D. Massachusetts General Hospital
More Information

Additional Information:

Responsible Party: Leigh R. Hochberg, MD, PhD., Sponsor-Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00912041     History of Changes
Other Study ID Numbers: MGH-BG2-TP-001
R01DC009899 ( U.S. NIH Grant/Contract )
RC1HD063931 ( U.S. NIH Grant/Contract )
R01HD077220 ( U.S. NIH Grant/Contract )
1UH2NS095548 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

Keywords provided by Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital:
Brain computer interface
Assistive device
Environmental control
Communication device

Additional relevant MeSH terms:
Spinal Cord Injuries
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Muscular Dystrophies
Brain Stem Infarctions
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurodegenerative Diseases
Neuromuscular Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Neurologic Manifestations
Signs and Symptoms
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders