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:

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

Tracking Information

First Submitted Date ^ICMJE

June 1, 2009

First Posted Date ^ICMJE

June 3, 2009

Last Update Posted Date

September 14, 2016

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

September 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00912041 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)

Condition ^ICMJE

Tetraplegia
Spinal Cord Injuries
Amyotrophic Lateral Sclerosis
Brain Stem Infarctions
Locked in Syndrome
Muscular Dystrophy

Intervention ^ICMJE

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

Study Arms

BrainGate

BrainGate Neural Interface System

Intervention: Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2021

Estimated Primary Completion Date

September 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Leigh R Hochberg, M.D., Ph.D.

617-724-9247

clinicaltrials@braingate.org

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00912041

Other Study ID Numbers ^ICMJE

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 )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital

Study Sponsor ^ICMJE

Leigh R. Hochberg, MD, PhD.

Collaborators ^ICMJE

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 ^ICMJE

Principal Investigator:

Leigh R Hochberg, M.D., PH.D.

Massachusetts General Hospital

PRS Account

Massachusetts General Hospital

Verification Date

September 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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