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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00912041
Recruitment Status : Recruiting
First Posted : June 3, 2009
Last Update Posted : January 10, 2023
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
US Department of Veterans Affairs
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital

Study Description
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Brief Summary:
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 2038
Estimated Study Completion Date : December 2038

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
BrainGate
BrainGate Neural Interface System
 Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex
Up to four 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one or two percutaneous pedestals. 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
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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
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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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


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

Locations
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United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: David M Brandman, MD, PhD    916-703-5010    braingate@ucdavis.edu   
Principal Investigator: David M Brandman, MD, PhD         
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, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Yvan Bamps, Ph.D.    404-778-7673    braingate@emory.edu   
Principal Investigator: Nicholas Au Yong, M.D., Ph.D.         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Leigh R Hochberg, MD, PhD    617-742-9247    lhochberg@mgh.harvard.edu   
Principal Investigator: Leigh R Hochberg, M.D., Ph.D.         
Sub-Investigator: Sydney S Cash, M.D., Ph.D.         
Sub-Investigator: Ziv Williams, M.D., Ph.D.         
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 Institute on Deafness and Other Communication Disorders (NIDCD)
US Department of Veterans Affairs
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Leigh R Hochberg, M.D., Ph.D. Massachusetts General Hospital
More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Leigh R. Hochberg, MD, PhD., Sponsor-Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00912041    
Other Study ID Numbers: MGH-BG2-TP-001
R01DC009899 ( U.S. NIH Grant/Contract )
UH2NS095548 ( U.S. NIH Grant/Contract )
A2295-R ( Other Grant/Funding Number: U.S. Department of Veterans Affairs )
U01NS123101 ( U.S. NIH Grant/Contract )
R01DC014034 ( U.S. NIH Grant/Contract )
U01DC017844 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: December 2022
Keywords provided by Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital:
Brain computer interface
Assistive device
Environmental control
 Communication device
quadriplegia
tetraplegia
Additional relevant MeSH terms:
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Muscular Dystrophies
Spinal Cord Injuries
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Quadriplegia
Locked-In Syndrome
Brain Stem Infarctions
Pathologic Processes
Infarction
Ischemia
Necrosis
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
Paralysis
Neurologic Manifestations
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders