- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02843919
Karakterisering af uafhængig opgave neurale korrelater af forskellige niveauer af mental arbejdsbelastning (CARACOg)
Målet er at identificere neurofysiologiske signaturer på flere niveauer af mental arbejdsbelastning under realiseringen af opgaver, udført af alle fagene.
Parallelt hermed vil der være et metodisk arbejde bestående af at udvikle klassifikationsalgoritmerne, forudsigelser af disse niveauer af mental arbejdsbelastning i realtid, med det formål at implementere en passiv hjerne-maskine-grænseflade i bedste interesse for operatører, der udfører komplekse opgaver.
Målinger af elektrofysiologisk aktivitet vil blive registreret for at godkende ladningstilstande ud over adfærdspræstationer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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La Tronche, Frankrig, 38700
- UniversityHospitalGrenoble
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- Underskrevet informeret samtykke
- Lægeundersøgelse foretaget før eftersøgning
- Mellem 20 og 40 år
- Højrehåndet
- Minimum studieniveau: Baccalauréat
- Medlemskab af den franske socialsikring
- Normalt syn og hørelse (eller korrigeret til normalt)
Ekskluderingskriterier:
- Forsøgspersoner inkluderet i et igangværende klinisk eller terapeutisk forsøg
- Syn eller hørelse væsentlig lidelse
- Neurologisk eller neuropsykiatrisk patologi nuværende eller væk
- Lægemiddelbehandling, der kan ændre hjerneaktivitet (antidepressiva, benzodiazepin, lithium osv.)
- Gravide, fødende eller ammende kvinder
- Alle andre kategorier af beskyttede personer
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: Sunde frivillige
Voksne raske frivillige
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Elektroencefalografi (EEG)
Tidsramme: 10 minutter
|
Med EEG hjelm. Klassisk Stembergs opgave Stembergs opgave med tidspres N-back opgave Hovedregningsopgave 13 minutter MATB Multi-Attribute Opgave Batteri : Opdelt opmærksomhedsopgave |
10 minutter
|
|
Elektrookulografi (EOG)
Tidsramme: 10 minutter
|
Samtidig med EEG: elektrookulografi (EOG) vil blive optaget Med EEG hjelm. Klassisk Stembergs opgave Stembergs opgave med tidspres N-back opgave Hovedregningsopgave 13 minutter MATB Multi-Attribute Opgave Batteri : Opdelt opmærksomhedsopgave |
10 minutter
|
|
Subjektive og adfærdsmæssige data
Tidsramme: 10 minutter
|
KSS-skala til at evaluere patientens alarmtilstand Klassisk Stembergs opgave Stembergs opgave med tidspres N-back opgave Hovedregningsopgave 13 minutter MATB Multi-Attribute Opgave Batteri : Opdelt opmærksomhedsopgave |
10 minutter
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Laurent Verceuil, Doctor, Grenoble Hospital University
Publikationer og nyttige links
Generelle publikationer
- Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.
- Gevins A, Smith ME. Neurophysiological measures of working memory and individual differences in cognitive ability and cognitive style. Cereb Cortex. 2000 Sep;10(9):829-39. doi: 10.1093/cercor/10.9.829.
- KIRCHNER WK. Age differences in short-term retention of rapidly changing information. J Exp Psychol. 1958 Apr;55(4):352-8. doi: 10.1037/h0043688. No abstract available.
- Allison BZ, Polich J. Workload assessment of computer gaming using a single-stimulus event-related potential paradigm. Biol Psychol. 2008 Mar;77(3):277-83. doi: 10.1016/j.biopsycho.2007.10.014. Epub 2007 Nov 4.
- Antonenko, P., Paas, F., Grabner, R., & Gog, T. (2010). Using Electroencephalography to Measure Cognitive Load. Educational Psychology Review, 22, 425-438.
- Baldwin CL, Penaranda BN. Adaptive training using an artificial neural network and EEG metrics for within- and cross-task workload classification. Neuroimage. 2012 Jan 2;59(1):48-56. doi: 10.1016/j.neuroimage.2011.07.047. Epub 2011 Jul 30.
- Barachant, A. (2012) Commande robuste d'un effecteur par une interface cerveau-machine EEG asynchrone. (Unpublished doctoral dissertation). Université de Grenoble, Grenoble, France.
- Bashashati A, Fatourechi M, Ward RK, Birch GE. A survey of signal processing algorithms in brain-computer interfaces based on electrical brain signals. J Neural Eng. 2007 Jun;4(2):R32-57. doi: 10.1088/1741-2560/4/2/R03. Epub 2007 Mar 27.
- Berka C, Levendowski DJ, Lumicao MN, Yau A, Davis G, Zivkovic VT, Olmstead RE, Tremoulet PD, Craven PL. EEG correlates of task engagement and mental workload in vigilance, learning, and memory tasks. Aviat Space Environ Med. 2007 May;78(5 Suppl):B231-44.
- Besserve, M., Martinerie, J., & Garnero, L. (2008). Non-invasive classification of cortical activities for brain computer interface: A variable selection approach (p. 1063-1066). IEEE.
- Brouwer AM, Hogervorst MA, van Erp JB, Heffelaar T, Zimmerman PH, Oostenveld R. Estimating workload using EEG spectral power and ERPs in the n-back task. J Neural Eng. 2012 Aug;9(4):045008. doi: 10.1088/1741-2560/9/4/045008. Epub 2012 Jul 25.
- Cain, B. (2007) "A review of the mental workload literature 1.0".
- Christensen JC, Estepp JR, Wilson GF, Russell CA. The effects of day-to-day variability of physiological data on operator functional state classification. Neuroimage. 2012 Jan 2;59(1):57-63. doi: 10.1016/j.neuroimage.2011.07.091. Epub 2011 Aug 5.
- Comstock, J. R., Jr., & Arnegard, R. J. (1992) The Multi-Attribute Task Battery for human operator workload and strategic behavior research (NASA TM-104174). Hampton, Virginia: NASA Langley Research Center.
- Dussault C, Jouanin JC, Philippe M, Guezennec CY. EEG and ECG changes during simulator operation reflect mental workload and vigilance. Aviat Space Environ Med. 2005 Apr;76(4):344-51.
- Fu, S. & Parasuraman, R. (2007) Event-related potentials (ERPs) in Neuroergonomics. . In Parasuraman, R. & Rizzo, M. (Eds), Neuroergonomics: The brain at work (pp. 15-31). New York, NY: Oxford University Press, Inc.
- George, L., & Lécuyer, A. (2010). An overview of research on " passive " brain-computer interfaces for implicit human-computer interaction. International Conference on Applied Bionics and Biomechanics (ICABB), Venice, Italy, October 14-16, 2010.
- Gevins, A., & Smith, M. E. (2003). Neurophysiological measures of cognitive workload during human-computer interaction. Theoretical Issues in Ergonomics Science, 1, 113-131.
- Gevins, A. & Smith, M. E. (2007) Electroencephalography (EEG) in Neuroergnomics. In Parasuraman, R. & Rizzo, M. (Eds), Neuroergonomics: The brain at work (pp. 15-31). New York, NY: Oxford University Press, Inc.
- Gomarus HK, Althaus M, Wijers AA, Minderaa RB. The effects of memory load and stimulus relevance on the EEG during a visual selective memory search task: an ERP and ERD/ERS study. Clin Neurophysiol. 2006 Apr;117(4):871-84. doi: 10.1016/j.clinph.2005.12.008. Epub 2006 Jan 25.
- Graimann, B, Allison, B. & Pfurstscheller, G. (2010) Brain-computer interfaces: A gentle introduction. In Graimann, B, Allison, B. & Pfurstscheller, G. (Eds) Brain-computer interfaces: Revolutionizing human-computer interaction, (pp. 1-28), Berlin Heidelberg, Springer-Verlag.
- Grimes, D., Tan, D. S., Hudson, S. E., Shenoy, P., & Rao, R. P. N. (2008). Feasibility and pragmatics of classifying working memory load with an electroencephalograph (p. 835). ACM Press.
- Heger, D., Putze, F., & Schultz, T. (2010). Online workload recognition from EEG data during cognitive tests and human-machine interaction. KI 2010: Advances in Artificial Intelligence, 410-417.
- Henelius A, Hirvonen K, Holm A, Korpela J, Muller K. Mental workload classification using heart rate metrics. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:1836-9. doi: 10.1109/IEMBS.2009.5332602.
- Holland MK, Tarlow G. Blinking and mental load. Psychol Rep. 1972 Aug;31(1):119-27. doi: 10.2466/pr0.1972.31.1.119. No abstract available.
- Holm A, Lukander K, Korpela J, Sallinen M, Muller KM. Estimating brain load from the EEG. ScientificWorldJournal. 2009 Jul 14;9:639-51. doi: 10.1100/tsw.2009.83.
- Honal, M., & Schultz, T. (2008). Determine task demand from brain activity. In Proceedings of the 3rd International Conference on Bio-inspired Systems and Signal Processing.
- Kahol K, Smith M, Brandenberger J, Ashby A, Ferrara JJ. Impact of fatigue on neurophysiologic measures of surgical residents. J Am Coll Surg. 2011 Jul;213(1):29-34; discussion 34-6. doi: 10.1016/j.jamcollsurg.2011.03.028. Epub 2011 Apr 23.
- Kok A. On the utility of P3 amplitude as a measure of processing capacity. Psychophysiology. 2001 May;38(3):557-77. doi: 10.1017/s0048577201990559.
- Koles ZJ, Flor-Henry P. Mental activity and the e.e.g.: task and workload related effects. Med Biol Eng Comput. 1981 Mar;19(2):185-94. doi: 10.1007/BF02442714. No abstract available.
- D. Levendowsk, Z. Konstantinovic, R. Olmstead, and C. Berka (2000). Method for the quantification of human alertness, patent.
- Lotte F, Congedo M, Lecuyer A, Lamarche F, Arnaldi B. A review of classification algorithms for EEG-based brain-computer interfaces. J Neural Eng. 2007 Jun;4(2):R1-R13. doi: 10.1088/1741-2560/4/2/R01. Epub 2007 Jan 31.
- McDonald NJ, Soussou W. QUASAR's QStates cognitive gauge performance in the cognitive state assessment competition 2011. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:6542-6. doi: 10.1109/IEMBS.2011.6091614.
- Miller MW, Rietschel JC, McDonald CG, Hatfield BD. A novel approach to the physiological measurement of mental workload. Int J Psychophysiol. 2011 Apr;80(1):75-8. doi: 10.1016/j.ijpsycho.2011.02.003. Epub 2011 Feb 20.
- Missonnier P, Deiber MP, Gold G, Millet P, Gex-Fabry Pun M, Fazio-Costa L, Giannakopoulos P, Ibanez V. Frontal theta event-related synchronization: comparison of directed attention and working memory load effects. J Neural Transm (Vienna). 2006 Oct;113(10):1477-86. doi: 10.1007/s00702-005-0443-9. Epub 2006 Apr 11.
- Natani, K., & Gomer, F. E. (1981). Electrocortical activity and operator workload: A comparison of changes in the electroencephalogram and in event-related potentials. (McDonnell Douglas Technical Report E2427). Long Beach, CA: McDonnell Douglas Corporation.
- Nourbakhsh, N., Wang, Y., & Chen, F. (2013). GSR and Blink Features for Cognitive Load Classification. In P. Kotzé, G. Marsden, G. Lindgaard, J. Wesson, & M. Winckler (Éd.), Human-Computer Interaction - INTERACT 2013 (Vol. 8117, p. 159-166). Berlin, Heidelberg: Springer Berlin Heidelberg.
- Ossandon T, Jerbi K, Vidal JR, Bayle DJ, Henaff MA, Jung J, Minotti L, Bertrand O, Kahane P, Lachaux JP. Transient suppression of broadband gamma power in the default-mode network is correlated with task complexity and subject performance. J Neurosci. 2011 Oct 12;31(41):14521-30. doi: 10.1523/JNEUROSCI.2483-11.2011.
- Putze, F., Jarvis, J. P., & Schultz, T. (2010) Multimodal Recognition of Cognitive Workload for Multitasking in the Car. International Conference on Pattern Recognition (ICPR), 20, 3748-3751.
- Schober F, Schellenberg R, Dimpfel W. Reflection of mental exercise in the dynamic quantitative topographical EEG. Neuropsychobiology. 1995;31(2):98-112. doi: 10.1159/000119179.
- Schultheis, H. & Jameson, A. (2004) Assessing Cognitive Load in Adaptive Hypermedia Systems: Physiological and Behavioral Methods. Lecture Notes in Computer Science, 313, 225-234.
- Sternberg S. High-speed scanning in human memory. Science. 1966 Aug 5;153(3736):652-4. doi: 10.1126/science.153.3736.652.
- Sternberg S. Memory-scanning: mental processes revealed by reaction-time experiments. Am Sci. 1969 Winter;57(4):421-57. No abstract available.
- Tanaka Y, Yamaoka K. Blink activity and task difficulty. Percept Mot Skills. 1993 Aug;77(1):55-66. doi: 10.2466/pms.1993.77.1.55.
- Tremoulet, P. D., Craven, P. L., Regli, S. H., Wilcox, S., Barton, J., Stibler and K., Clark, M. (2009). Workload-Based Assessment of a User Interface Design. In V. G. Duffy (Éd.), Digital Human Modeling (Vol. 5620, p. 333-342). Berlin, Heidelberg: Springer Berlin Heidelberg.
- Veltman JA, Gaillard AW. Physiological indices of workload in a simulated flight task. Biol Psychol. 1996 Feb 5;42(3):323-42. doi: 10.1016/0301-0511(95)05165-1.
- Wang Z, Hope RM, Wang Z, Ji Q, Gray WD. Cross-subject workload classification with a hierarchical Bayes model. Neuroimage. 2012 Jan 2;59(1):64-9. doi: 10.1016/j.neuroimage.2011.07.094. Epub 2011 Aug 16.
- Wolpaw JR, Birbaumer N, McFarland DJ, Pfurtscheller G, Vaughan TM. Brain-computer interfaces for communication and control. Clin Neurophysiol. 2002 Jun;113(6):767-91. doi: 10.1016/s1388-2457(02)00057-3.
- Zander, T.O., Kothe, C., Jatzev, S. & Gaertner, M. (2010) Enhancing human-computer interaction with input from active and passive brain-computer interfaces. In Tan, D.S. & Nijholt, A. (Eds) Brain-computer interfaces: Applying our minds to human-computer interaction (pp. 181-196), London, Springer-Verlag.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 38RC14.009
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .