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

This study is currently recruiting participants.

Verified by Massachusetts General Hospital, September 2009

First Received: June 1, 2009 Last Updated: September 17, 2009 History of Changes

Sponsor:	Massachusetts General Hospital
Collaborators:	National Center for Medical Rehabilitation Research Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	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:	Open Label, Single Group Assignment, Safety Study
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 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.

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 two-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, 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

Massachusetts General Hospital

National Center for Medical Rehabilitation Research

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.

Responsible Party:	Massachusetts General Hospital ( Leigh R. Hochberg, M.D., Ph.D. )
Study ID Numbers:	MGH-BG2-TP-001
Study First Received:	June 1, 2009
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00912041 History of Changes
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:

Spinal Cord Diseases
Disorders of Environmental Origin
Quadriplegia
Brain Diseases
Neurodegenerative Diseases
Cerebrovascular Disorders
Spinal Cord Injuries
Signs and Symptoms
Necrosis
Pathologic Processes
Neuromuscular Diseases
Syndrome
Brain Ischemia
Cardiovascular Diseases
Motor Neuron Disease

Disease
Stroke
Nervous System Diseases
Vascular Diseases
Wounds and Injuries
Central Nervous System Diseases
Sclerosis
Ischemia
Trauma, Nervous System
Brain Stem Infarctions
Paralysis
Amyotrophic Lateral Sclerosis
Neurologic Manifestations
Brain Infarction
Infarction

ClinicalTrials.gov processed this record on November 05, 2009