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)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

Department of Veterans Affairs

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

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 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:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Muscular Dystrophy

Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis Locked-in Syndrome Muscular Dystrophy

U.S. FDA Resources

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:

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)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

Department of Veterans Affairs

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. 2014 Nov 10. pii: 1545968314554624. [Epub ahead of print]

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.


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:


Brain Diseases 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 Neuromuscular Diseases Spinal Cord Diseases	Vascular Diseases Amyotrophic Lateral Sclerosis Brain Stem Infarctions Muscular Dystrophies Quadriplegia Brain Infarction Brain Ischemia Neurologic Manifestations Paralysis Proteostasis Deficiencies Signs and Symptoms Stroke TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on March 03, 2015

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