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

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
This study is currently recruiting participants.
Verified January 2012 by Massachusetts General Hospital

First Received on June 1, 2009.  
Last Updated on January 19, 2012  
History of Changes
Sponsor: Leigh R. Hochberg, MD, PhD.
Collaborators: 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)
Information provided by (Responsible Party): Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00912041
  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.

Condition Intervention
Tetraplegia
Spinal Cord Injuries
Amyotrophic Lateral Sclerosis
Brain Stem Infarctions
Locked in Syndrome
Device: Placement of the BrainGate2 sensor into the motor cortex

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: May 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Intervention Details:

    Device: Placement of the BrainGate2 sensor into the motor cortex

    The 4×4 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.
    Other Names:
    • BrainGate
    • NeuroPort
    • neural prosthesis
    • neural prosthetic
    • neuroprosthetic
    • brain computer interface
    • brain-computer interface

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912041

Contacts
Contact: Leigh R Hochberg, M.D., Ph.D. 617-726-4218 clinicaltrials@braingate2.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
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.            
Sponsors and Collaborators
Leigh R. Hochberg, MD, PhD.
National Center for Medical Rehabilitation Research (NCMRR)
Investigators
Principal Investigator: Leigh R Hochberg, M.D., PH.D. Massachusetts General Hospital
  More Information

Additional Information:

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, RC1HD063931
Study First Received: June 1, 2009
Last Updated: January 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

Brain computer interface
Assistive device
Environmental control
Communication device
quadriplegia
tetraplegia

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on August 21, 2012

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