BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
This study is currently recruiting participants.
Verified February 2013 by Massachusetts General Hospital
Sponsor:
Leigh R. Hochberg, MD, PhD.
Collaborators:
National Center for Medical Rehabilitation Research (NCMRR)
Rehabilitation Research and Development Service, 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: February 19, 2013
Last verified: February 2013
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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:
Detailed Description:
-
Device: Placement of the BrainGate2 sensor into the motor cortex
- BrainGate
- NeuroPort
- neural prosthesis
- neural prosthetic
- neuroprosthetic
- brain computer interface
- brain-computer interface
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:
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. | |
| 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)
Rehabilitation Research and Development Service, Department of Veterans Affairs
Investigators
| Principal Investigator: | Leigh R Hochberg, M.D., PH.D. | Massachusetts General Hospital |
More Information
Additional Information:
Publications:
| 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: | February 19, 2013 |
| 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 May 22, 2013