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

This study is currently recruiting participants.
Verified September 2016 by Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00912041
First Posted: June 3, 2009
Last Update Posted: September 14, 2016
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.
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)
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
  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(s) into the motor-related cortex

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis
Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis Muscular Dystrophy Locked-in Syndrome
U.S. FDA Resources

Further study details as provided by Leigh R. Hochberg, MD, PhD., 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 ]

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 ]
Estimated Enrollment: 15
Study Start Date: May 2009
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
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)
Investigators
Principal Investigator: Leigh R Hochberg, M.D., PH.D. Massachusetts General Hospital
  More Information

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

Publications:
Simeral JD, Kim SP, Black MJ, Donoghue JP, Hochberg LR. Neural control of cursor trajectory and click by a human with tetraplegia 1000 days after implant of an intracortical microelectrode array. J Neural Eng. 2011 Apr;8(2):025027. doi: 10.1088/1741-2560/8/2/025027. Epub 2011 Mar 24.
Hochberg LR, Bacher D, Jarosiewicz B, Masse NY, Simeral JD, Vogel J, Haddadin S, Liu J, Cash SS, van der Smagt P, Donoghue JP. Reach and grasp by people with tetraplegia using a neurally controlled robotic arm. Nature. 2012 May 16;485(7398):372-5. doi: 10.1038/nature11076.
Bacher D, Jarosiewicz B, Masse NY, Stavisky SD, Simeral JD, Newell K, Oakley EM, Cash SS, Friehs G, Hochberg LR. Neural Point-and-Click Communication by a Person With Incomplete Locked-In Syndrome. Neurorehabil Neural Repair. 2015 Jun;29(5):462-71. doi: 10.1177/1545968314554624. Epub 2014 Nov 10.
Gilja V, Pandarinath C, Blabe CH, Nuyujukian P, Simeral JD, Sarma AA, Sorice BL, Perge JA, Jarosiewicz B, Hochberg LR, Shenoy KV, Henderson JM. Clinical translation of a high-performance neural prosthesis. Nat Med. 2015 Oct;21(10):1142-5. doi: 10.1038/nm.3953. Epub 2015 Sep 28.
Hochberg LR, Serruya MD, Friehs GM, Mukand JA, Saleh M, Caplan AH, Branner A, Chen D, Penn RD, Donoghue JP. Neuronal ensemble control of prosthetic devices by a human with tetraplegia. Nature. 2006 Jul 13;442(7099):164-71.
Donoghue JP, Nurmikko A, Black M, Hochberg LR. Assistive technology and robotic control using motor cortex ensemble-based neural interface systems in humans with tetraplegia. J Physiol. 2007 Mar 15;579(Pt 3):603-11. Epub 2007 Feb 1. Review.
Jarosiewicz B, Masse NY, Bacher D, Cash SS, Eskandar E, Friehs G, Donoghue JP, Hochberg LR. Advantages of closed-loop calibration in intracortical brain-computer interfaces for people with tetraplegia. J Neural Eng. 2013 Aug;10(4):046012. doi: 10.1088/1741-2560/10/4/046012. Epub 2013 Jul 10.
Homer ML, Perge JA, Black MJ, Harrison MT, Cash SS, Hochberg LR. Adaptive offset correction for intracortical brain-computer interfaces. IEEE Trans Neural Syst Rehabil Eng. 2014 Mar;22(2):239-48. doi: 10.1109/TNSRE.2013.2287768.
Perge JA, Zhang S, Malik WQ, Homer ML, Cash S, Friehs G, Eskandar EN, Donoghue JP, Hochberg LR. Reliability of directional information in unsorted spikes and local field potentials recorded in human motor cortex. J Neural Eng. 2014 Aug;11(4):046007. doi: 10.1088/1741-2560/11/4/046007. Epub 2014 Jun 12.
Masse NY, Jarosiewicz B, Simeral JD, Bacher D, Stavisky SD, Cash SS, Oakley EM, Berhanu E, Eskandar E, Friehs G, Hochberg LR, Donoghue JP. Non-causal spike filtering improves decoding of movement intention for intracortical BCIs. J Neurosci Methods. 2014 Oct 30;236:58-67. doi: 10.1016/j.jneumeth.2014.08.004. Epub 2014 Aug 13.
Malik WQ, Hochberg LR, Donoghue JP, Brown EN. Modulation depth estimation and variable selection in state-space models for neural interfaces. IEEE Trans Biomed Eng. 2015 Feb;62(2):570-81. doi: 10.1109/TBME.2014.2360393. Epub 2014 Sep 26.
Pandarinath C, Gilja V, Blabe CH, Nuyujukian P, Sarma AA, Sorice BL, Eskandar EN, Hochberg LR, Henderson JM, Shenoy KV. Neural population dynamics in human motor cortex during movements in people with ALS. Elife. 2015 Jun 23;4:e07436. doi: 10.7554/eLife.07436.

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 Submitted: June 1, 2009
First Posted: June 3, 2009
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
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


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