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:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis Assistive Devices Mobility Aids Spinal Cord Injuries

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 2015
Estimated Primary Completion Date:	September 2015 (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

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)

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

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:

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.

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. Epub 2011 Mar 24.

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 February 09, 2012