June 1, 2009
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June 3, 2009
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May 19, 2020
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May 2009
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September 2022 (Final data collection date for primary outcome measure)
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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 ]
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Same as current
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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 ]
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Same as current
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Not Provided
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Not Provided
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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
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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.
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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.
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Interventional
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Not Applicable
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Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other
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- Tetraplegia
- Spinal Cord Injuries
- Amyotrophic Lateral Sclerosis
- Brain Stem Infarctions
- Locked in Syndrome
- Muscular Dystrophy
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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
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BrainGate
BrainGate Neural Interface System
Intervention: Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex
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- 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.
- Homer ML, Perge JA, Black MJ, Harrison MT, Cash SS, Hochberg LR. Adaptive offset correction for intracortical brain-computer interfaces. IEEE Trans Neural Syst Rehabil Eng. 2014 Mar;22(2):239-48. doi: 10.1109/TNSRE.2013.2287768.
- Perge JA, Zhang S, Malik WQ, Homer ML, Cash S, Friehs G, Eskandar EN, Donoghue JP, Hochberg LR. Reliability of directional information in unsorted spikes and local field potentials recorded in human motor cortex. J Neural Eng. 2014 Aug;11(4):046007. doi: 10.1088/1741-2560/11/4/046007. Epub 2014 Jun 12.
- Masse NY, Jarosiewicz B, Simeral JD, Bacher D, Stavisky SD, Cash SS, Oakley EM, Berhanu E, Eskandar E, Friehs G, Hochberg LR, Donoghue JP. Non-causal spike filtering improves decoding of movement intention for intracortical BCIs. J Neurosci Methods. 2014 Oct 30;236:58-67. doi: 10.1016/j.jneumeth.2014.08.004. Epub 2014 Aug 13.
- Malik WQ, Hochberg LR, Donoghue JP, Brown EN. Modulation depth estimation and variable selection in state-space models for neural interfaces. IEEE Trans Biomed Eng. 2015 Feb;62(2):570-81. doi: 10.1109/TBME.2014.2360393. Epub 2014 Sep 26.
- Pandarinath C, Gilja V, Blabe CH, Nuyujukian P, Sarma AA, Sorice BL, Eskandar EN, Hochberg LR, Henderson JM, Shenoy KV. Neural population dynamics in human motor cortex during movements in people with ALS. Elife. 2015 Jun 23;4:e07436. doi: 10.7554/eLife.07436.
- Pandarinath C, O'Shea DJ, Collins J, Jozefowicz R, Stavisky SD, Kao JC, Trautmann EM, Kaufman MT, Ryu SI, Hochberg LR, Henderson JM, Shenoy KV, Abbott LF, Sussillo D. Inferring single-trial neural population dynamics using sequential auto-encoders. Nat Methods. 2018 Oct;15(10):805-815. doi: 10.1038/s41592-018-0109-9. Epub 2018 Sep 17.
- Willett FR, Murphy BA, Young DR, Memberg WD, Blabe CH, Pandarinath C, Franco B, Saab J, Walter BL, Sweet JA, Miller JP, Henderson JM, Shenoy KV, Simeral JD, Jarosiewicz B, Hochberg LR, Kirsch RF, Ajiboye AB. A Comparison of Intention Estimation Methods for Decoder Calibration in Intracortical Brain-Computer Interfaces. IEEE Trans Biomed Eng. 2018 Sep;65(9):2066-2078. doi: 10.1109/TBME.2017.2783358. Epub 2017 Dec 14.
- Brandman DM, Burkhart MC, Kelemen J, Franco B, Harrison MT, Hochberg LR. Robust Closed-Loop Control of a Cursor in a Person with Tetraplegia using Gaussian Process Regression. Neural Comput. 2018 Nov;30(11):2986-3008. doi: 10.1162/neco_a_01129. Epub 2018 Sep 14.
- Vargas-Irwin CE, Feldman JM, King B, Simeral JD, Sorice BL, Oakley EM, Cash SS, Eskandar EN, Friehs GM, Hochberg LR, Donoghue JP. Watch, Imagine, Attempt: Motor Cortex Single-Unit Activity Reveals Context-Dependent Movement Encoding in Humans With Tetraplegia. Front Hum Neurosci. 2018 Nov 15;12:450. doi: 10.3389/fnhum.2018.00450. eCollection 2018.
- Simeral JD, Kim SP, Black MJ, Donoghue JP, Hochberg LR. Neural control of cursor trajectory and click by a human with tetraplegia 1000 days after implant of an intracortical microelectrode array. J Neural Eng. 2011 Apr;8(2):025027. doi: 10.1088/1741-2560/8/2/025027. Epub 2011 Mar 24.
- Hochberg LR, Bacher D, Jarosiewicz B, Masse NY, Simeral JD, Vogel J, Haddadin S, Liu J, Cash SS, van der Smagt P, Donoghue JP. Reach and grasp by people with tetraplegia using a neurally controlled robotic arm. Nature. 2012 May 16;485(7398):372-5. doi: 10.1038/nature11076.
- Jarosiewicz B, Masse NY, Bacher D, Cash SS, Eskandar E, Friehs G, Donoghue JP, Hochberg LR. Advantages of closed-loop calibration in intracortical brain-computer interfaces for people with tetraplegia. J Neural Eng. 2013 Aug;10(4):046012. doi: 10.1088/1741-2560/10/4/046012. Epub 2013 Jul 10.
- Bacher D, Jarosiewicz B, Masse NY, Stavisky SD, Simeral JD, Newell K, Oakley EM, Cash SS, Friehs G, Hochberg LR. Neural Point-and-Click Communication by a Person With Incomplete Locked-In Syndrome. Neurorehabil Neural Repair. 2015 Jun;29(5):462-71. doi: 10.1177/1545968314554624. Epub 2014 Nov 10.
- Gilja V, Pandarinath C, Blabe CH, Nuyujukian P, Simeral JD, Sarma AA, Sorice BL, Perge JA, Jarosiewicz B, Hochberg LR, Shenoy KV, Henderson JM. Clinical translation of a high-performance neural prosthesis. Nat Med. 2015 Oct;21(10):1142-5. doi: 10.1038/nm.3953. Epub 2015 Sep 28.
- Ajiboye AB, Willett FR, Young DR, Memberg WD, Murphy BA, Miller JP, Walter BL, Sweet JA, Hoyen HA, Keith MW, Peckham PH, Simeral JD, Donoghue JP, Hochberg LR, Kirsch RF. Restoration of reaching and grasping movements through brain-controlled muscle stimulation in a person with tetraplegia: a proof-of-concept demonstration. Lancet. 2017 May 6;389(10081):1821-1830. doi: 10.1016/S0140-6736(17)30601-3. Epub 2017 Mar 28.
- Pandarinath C, Nuyujukian P, Blabe CH, Sorice BL, Saab J, Willett FR, Hochberg LR, Shenoy KV, Henderson JM. High performance communication by people with paralysis using an intracortical brain-computer interface. Elife. 2017 Feb 21;6. pii: e18554. doi: 10.7554/eLife.18554.
- Brandman DM, Hosman T, Saab J, Burkhart MC, Shanahan BE, Ciancibello JG, Sarma AA, Milstein DJ, Vargas-Irwin CE, Franco B, Kelemen J, Blabe C, Murphy BA, Young DR, Willett FR, Pandarinath C, Stavisky SD, Kirsch RF, Walter BL, Bolu Ajiboye A, Cash SS, Eskandar EN, Miller JP, Sweet JA, Shenoy KV, Henderson JM, Jarosiewicz B, Harrison MT, Simeral JD, Hochberg LR. Rapid calibration of an intracortical brain-computer interface for people with tetraplegia. J Neural Eng. 2018 Apr;15(2):026007. doi: 10.1088/1741-2552/aa9ee7.
- Nuyujukian P, Albites Sanabria J, Saab J, Pandarinath C, Jarosiewicz B, Blabe CH, Franco B, Mernoff ST, Eskandar EN, Simeral JD, Hochberg LR, Shenoy KV, Henderson JM. Cortical control of a tablet computer by people with paralysis. PLoS One. 2018 Nov 21;13(11):e0204566. doi: 10.1371/journal.pone.0204566. eCollection 2018.
- Brandman DM, Cash SS, Hochberg LR. Review: Human Intracortical Recording and Neural Decoding for Brain-Computer Interfaces. IEEE Trans Neural Syst Rehabil Eng. 2017 Oct;25(10):1687-1696. doi: 10.1109/TNSRE.2017.2677443. Epub 2017 Mar 2. Review.
- Willett FR, Pandarinath C, Jarosiewicz B, Murphy BA, Memberg WD, Blabe CH, Saab J, Walter BL, Sweet JA, Miller JP, Henderson JM, Shenoy KV, Simeral JD, Hochberg LR, Kirsch RF, Ajiboye AB. Feedback control policies employed by people using intracortical brain-computer interfaces. J Neural Eng. 2017 Feb;14(1):016001. doi: 10.1088/1741-2560/14/1/016001. Epub 2016 Nov 30.
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Recruiting
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15
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Same as current
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December 2022
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September 2022 (Final data collection date for primary outcome measure)
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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)
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Sexes Eligible for Study: |
All |
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18 Years to 75 Years (Adult, Older Adult)
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No
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United States
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NCT00912041
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MGH-BG2-TP-001 R01DC009899 ( U.S. NIH Grant/Contract ) 1UH2NS095548 ( U.S. NIH Grant/Contract )
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Yes
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Not Provided
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Not Provided
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Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
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Leigh R. Hochberg, MD, PhD.
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- National Institute on Deafness and Other Communication Disorders (NIDCD)
- US Department of Veterans Affairs
- National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: |
Leigh R Hochberg, M.D., PH.D. |
Massachusetts General Hospital |
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Massachusetts General Hospital
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May 2020
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