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

This study is currently recruiting participants.

See

Contacts and Locations

Verified September 2016 by Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital

Sponsor:

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

ClinicalTrials.gov Identifier:

NCT00912041

First received: June 1, 2009

Last updated: September 12, 2016

Last verified: September 2016

History of Changes

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: 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

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


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

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@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 )
Study First Received:	June 1, 2009
Last Updated:	September 12, 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

ClinicalTrials.gov processed this record on July 21, 2017

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