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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Massachusetts General Hospital
Sponsor:
Collaborators:
National Center for Medical Rehabilitation Research (NCMRR)
Information provided by (Responsible Party):
Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00912041
First received: June 1, 2009
Last updated: March 2, 2015
Last verified: March 2015
  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
Muscular Dystrophy
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 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Placement of the BrainGate2 sensor into the motor cortex
    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.
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Leigh R Hochberg, M.D., Ph.D. 617-724-9247 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.         
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: Andrew Cornwell, PhD    216-502-2887    andrew.cornwell@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)
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, R01HD077220
Study First Received: June 1, 2009
Last Updated: March 2, 2015
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
Brain Stem Infarctions
Muscular Dystrophies
Quadriplegia
Spinal Cord Injuries
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Genetic Diseases, Inborn
Metabolic Diseases
Motor Neuron Disease
Muscular Diseases
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Neuromuscular Diseases
Paralysis
Proteostasis Deficiencies
Signs and Symptoms
Spinal Cord Diseases
Stroke
TDP-43 Proteinopathies
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on July 05, 2015