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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 : March 29, 2018
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
VA Office of Research and Development
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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 to recover a host of abilities that normally rely on the hands.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
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
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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 75 Years   (Adult, Senior)
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
Contact: Leigh R Hochberg, M.D., Ph.D. 617-724-9247 clinicaltrials@braingate.org

Locations
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
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: 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 Institute on Deafness and Other Communication Disorders (NIDCD)
VA Office of Research and Development
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Leigh R Hochberg, M.D., PH.D. Massachusetts General Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Home Page for BrainGate Research  This link exits the ClinicalTrials.gov site

Publications of Results:

Other Publications:

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 )
1UH2NS095548 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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