BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia (BrainGate2)
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ClinicalTrials.gov Identifier: NCT00912041 |
Recruitment Status
:
Recruiting
First Posted
: June 3, 2009
Last Update Posted
: March 29, 2018
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Sponsor:
Leigh R. Hochberg, MD, PhD.
Collaborators:
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 | |||||
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First Submitted Date ICMJE | June 1, 2009 | ||||
First Posted Date ICMJE | June 3, 2009 | ||||
Last Update Posted Date | March 29, 2018 | ||||
Study 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 Applicable | ||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE |
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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:
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Study Arms | BrainGate
BrainGate Neural Interface System
Intervention: Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
15 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date | December 2021 | ||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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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 ) 1UH2NS095548 ( U.S. NIH Grant/Contract ) |
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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 |
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Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | ||||
Verification Date | March 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |