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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia (BrainGate2)
This study is currently recruiting participants.
Verified September 2016 by Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
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)
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
ClinicalTrials.gov Identifier:
NCT00912041
First received: June 1, 2009
Last updated: September 12, 2016
Last verified: September 2016
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| First Received Date ICMJE | June 1, 2009 | ||||
| Last Updated Date | September 12, 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: Open Label |
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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 | ||||
| Estimated 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 ( US NIH Grant/Contract Award Number ) RC1HD063931 ( US NIH Grant/Contract Award Number ) R01HD077220 ( US NIH Grant/Contract Award Number ) 1UH2NS095548 ( US NIH Grant/Contract Award Number ) |
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| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| Plan to Share Data | Not Provided | ||||
| IPD Description | 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 | September 2016 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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