BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
NCT ID: NCT00912041
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
27 participants
INTERVENTIONAL
2009-05-31
2038-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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BrainGate
BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into the motor-related cortex
Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
Interventions
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Placement of the BrainGate2 sensor(s) into the motor-related cortex
Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Complete or incomplete tetraplegia (quadriplegia)
* Must live within a three-hour drive of the Study site
Exclusion Criteria
* Chronic oral or intravenous steroids or immunosuppressive therapy
* Other serious disease or disorder that could seriously affect ability to participate in the study
18 Years
80 Years
ALL
No
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
US Department of Veterans Affairs
FED
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Leigh R. Hochberg, MD, PhD.
OTHER
Responsible Party
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Leigh R. Hochberg, MD, PhD.
Sponsor-Investigator
Principal Investigators
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Leigh R Hochberg, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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University of California, Davis
Sacramento, California, United States
Stanford University School of Medicine
Stanford, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Providence VA Medical Center
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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. doi: 10.1038/nature04970.
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. doi: 10.1113/jphysiol.2006.127209. Epub 2007 Feb 1.
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.
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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.
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Willett FR, Avansino DT, Hochberg LR, Henderson JM, Shenoy KV. High-performance brain-to-text communication via handwriting. Nature. 2021 May;593(7858):249-254. doi: 10.1038/s41586-021-03506-2. Epub 2021 May 12.
Deo DR, Rezaii P, Hochberg LR, M Okamura A, Shenoy KV, Henderson JM. Effects of Peripheral Haptic Feedback on Intracortical Brain-Computer Interface Control and Associated Sensory Responses in Motor Cortex. IEEE Trans Haptics. 2021 Oct-Dec;14(4):762-775. doi: 10.1109/TOH.2021.3072615. Epub 2021 Dec 17.
Simeral JD, Hosman T, Saab J, Flesher SN, Vilela M, Franco B, Kelemen JN, Brandman DM, Ciancibello JG, Rezaii PG, Eskandar EN, Rosler DM, Shenoy KV, Henderson JM, Nurmikko AV, Hochberg LR. Home Use of a Percutaneous Wireless Intracortical Brain-Computer Interface by Individuals With Tetraplegia. IEEE Trans Biomed Eng. 2021 Jul;68(7):2313-2325. doi: 10.1109/TBME.2021.3069119. Epub 2021 Jun 17.
Rastogi A, Willett FR, Abreu J, Crowder DC, Murphy BA, Memberg WD, Vargas-Irwin CE, Miller JP, Sweet J, Walter BL, Rezaii PG, Stavisky SD, Hochberg LR, Shenoy KV, Henderson JM, Kirsch RF, Ajiboye AB. The Neural Representation of Force across Grasp Types in Motor Cortex of Humans with Tetraplegia. eNeuro. 2021 Feb 19;8(1):ENEURO.0231-20.2020. doi: 10.1523/ENEURO.0231-20.2020. Print 2021 Jan-Feb.
Hosman T, Hynes JB, Saab J, Wilcoxen KG, Buchbinder BR, Schmansky N, Cash SS, Eskandar EN, Simeral JD, Franco B, Kelemen J, Vargas-Irwin CE, Hochberg LR. Auditory cues reveal intended movement information in middle frontal gyrus neuronal ensemble activity of a person with tetraplegia. Sci Rep. 2021 Jan 11;11(1):98. doi: 10.1038/s41598-020-77616-8.
Wilson GH, Stavisky SD, Willett FR, Avansino DT, Kelemen JN, Hochberg LR, Henderson JM, Druckmann S, Shenoy KV. Decoding spoken English from intracortical electrode arrays in dorsal precentral gyrus. J Neural Eng. 2020 Nov 25;17(6):066007. doi: 10.1088/1741-2552/abbfef.
Eichenlaub JB, Jarosiewicz B, Saab J, Franco B, Kelemen J, Halgren E, Hochberg LR, Cash SS. Replay of Learned Neural Firing Sequences during Rest in Human Motor Cortex. Cell Rep. 2020 May 5;31(5):107581. doi: 10.1016/j.celrep.2020.107581.
Stavisky SD, Willett FR, Avansino DT, Hochberg LR, Shenoy KV, Henderson JM. Speech-related dorsal motor cortex activity does not interfere with iBCI cursor control. J Neural Eng. 2020 Feb 5;17(1):016049. doi: 10.1088/1741-2552/ab5b72.
Rastogi A, Vargas-Irwin CE, Willett FR, Abreu J, Crowder DC, Murphy BA, Memberg WD, Miller JP, Sweet JA, Walter BL, Cash SS, Rezaii PG, Franco B, Saab J, Stavisky SD, Shenoy KV, Henderson JM, Hochberg LR, Kirsch RF, Ajiboye AB. Neural Representation of Observed, Imagined, and Attempted Grasping Force in Motor Cortex of Individuals with Chronic Tetraplegia. Sci Rep. 2020 Jan 29;10(1):1429. doi: 10.1038/s41598-020-58097-1.
Stavisky SD, Willett FR, Wilson GH, Murphy BA, Rezaii P, Avansino DT, Memberg WD, Miller JP, Kirsch RF, Hochberg LR, Ajiboye AB, Druckmann S, Shenoy KV, Henderson JM. Neural ensemble dynamics in dorsal motor cortex during speech in people with paralysis. Elife. 2019 Dec 10;8:e46015. doi: 10.7554/eLife.46015.
Willett FR, Young DR, Murphy BA, Memberg WD, Blabe CH, Pandarinath C, Stavisky SD, Rezaii P, Saab J, Walter BL, Sweet JA, Miller JP, Henderson JM, Shenoy KV, Simeral JD, Jarosiewicz B, Hochberg LR, Kirsch RF, Bolu Ajiboye A. Principled BCI Decoder Design and Parameter Selection Using a Feedback Control Model. Sci Rep. 2019 Jun 20;9(1):8881. doi: 10.1038/s41598-019-44166-7.
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Young D, Willett F, Memberg WD, Murphy B, Rezaii P, Walter B, Sweet J, Miller J, Shenoy KV, Hochberg LR, Kirsch RF, Ajiboye AB. Closed-loop cortical control of virtual reach and posture using Cartesian and joint velocity commands. J Neural Eng. 2019 Apr;16(2):026011. doi: 10.1088/1741-2552/aaf606. Epub 2018 Dec 4.
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.
Rubin DB, Hosman T, Kelemen JN, Kapitonava A, Willett FR, Coughlin BF, Halgren E, Kimchi EY, Williams ZM, Simeral JD, Hochberg LR, Cash SS. Learned Motor Patterns Are Replayed in Human Motor Cortex during Sleep. J Neurosci. 2022 Jun 22;42(25):5007-5020. doi: 10.1523/JNEUROSCI.2074-21.2022. Epub 2022 May 19.
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.
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Related Links
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Home Page for BrainGate Research
Other Identifiers
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A2295-R
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CDMRP-AL220043
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
A4820-R
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MGH-BG2-TP-001
Identifier Type: -
Identifier Source: org_study_id
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