Healthy Volunteer Clinical Trial
— CARACOgOfficial title:
Characterization of Independant Task Neural Correlates of Different Levels of Mental Workload
NCT number | NCT02843919 |
Other study ID # | 38RC14.009 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2014 |
Est. completion date | December 2017 |
Verified date | October 2018 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal is to identify neuro-physiological signatures at several levels of mental workload
during the realisation of tasks, performed by all the subjects.
In parallel, there will be a methodological work consisting to develop the classification
algorithms, predictives of these levels of mental workload in real time, in purpose to
implement a passive brain-machine interface in the best interest of operators that accomplish
complex tasks.
Mesures of electro-physiological activity will be recorded in order to approve states of
charge in addition to behavioral performances.
Status | Terminated |
Enrollment | 19 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Signed informed consent - Medical examination made before search involvement - Between 20 and 40 years - Right-handed - Minimum study level : Baccalauréat - Membership of the French social security - Normal vision and hearing (or corrected to normal) Exclusion Criteria: - Sujects included in a clinical or therapeutic trial in progress - Vision or hearing essential disorder - Neurological or neuropsychiatric pathology current or gone - Drug treatment which could alter brain activity (antidepressants, benzodiazepine, lithium etc) - Pregnant, parturient or breast feeding women - All other category of protected people |
Country | Name | City | State |
---|---|---|---|
France | UniversityHospitalGrenoble | La Tronche |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. — View Citation
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. Epub 2007 Nov 4. — View Citation
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. — View Citation
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. Epub 2007 Mar 27. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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.
D. Levendowsk, Z. Konstantinovic, R. Olmstead, and C. Berka (2000). Method for the quantification of human alertness, patent.
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. — View Citation
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 ME. Neurophysiological measures of working memory and individual differences in cognitive ability and cognitive style. Cereb Cortex. 2000 Sep;10(9):829-39. — View Citation
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.
Gevins, A., & Smith, M. E. (2003). Neurophysiological measures of cognitive workload during human-computer interaction. Theoretical Issues in Ergonomics Science, 1, 113-131.
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. Epub 2006 Jan 25. — View Citation
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. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:1836-9. doi: 10.1109/IEMBS.2009.5332602. — View Citation
Holland MK, Tarlow G. Blinking and mental load. Psychol Rep. 1972 Aug;31(1):119-27. — View Citation
Holm A, Lukander K, Korpela J, Sallinen M, Müller KM. Estimating brain load from the EEG. ScientificWorldJournal. 2009 Jul 14;9:639-51. doi: 10.1100/tsw.2009.83. — View Citation
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. — View Citation
KIRCHNER WK. Age differences in short-term retention of rapidly changing information. J Exp Psychol. 1958 Apr;55(4):352-8. — View Citation
Kok A. On the utility of P3 amplitude as a measure of processing capacity. Psychophysiology. 2001 May;38(3):557-77. Review. — View Citation
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. — View Citation
Lotte F, Congedo M, Lécuyer 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. Epub 2007 Jan 31. Review. — View Citation
McDonald NJ, Soussou W. QUASAR's QStates cognitive gauge performance in the cognitive state assessment competition 2011. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:6542-6. doi: 10.1109/IEMBS.2011.6091614. — View Citation
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. — View Citation
Missonnier P, Deiber MP, Gold G, Millet P, Gex-Fabry Pun M, Fazio-Costa L, Giannakopoulos P, Ibáñez 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. Epub 2006 Apr 11. — View Citation
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.
Ossandón 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. — View Citation
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. — View Citation
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. — View Citation
Sternberg S. Memory-scanning: mental processes revealed by reaction-time experiments. Am Sci. 1969 Winter;57(4):421-57. — View Citation
Tanaka Y, Yamaoka K. Blink activity and task difficulty. Percept Mot Skills. 1993 Aug;77(1):55-66. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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.
* Note: There are 49 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Electroencephalography (EEG) | With a EEG helmet. Classical Stemberg's task Stemberg's task with time pressure N-back task Mental arithmetic task 13 minutes MATB Multi-Attribute Task Battery : Divided attention task |
10 minutes | |
Primary | Electrooculography (EOG) | Simultaneously to EEG : electrooculography (EOG) will be recorded With a EEG helmet. Classical Stemberg's task Stemberg's task with time pressure N-back task Mental arithmetic task 13 minutes MATB Multi-Attribute Task Battery : Divided attention task |
10 minutes | |
Primary | Subjective and behavioral data | KSS scale to evaluate the patient's state of alertness Classical Stemberg's task Stemberg's task with time pressure N-back task Mental arithmetic task 13 minutes MATB Multi-Attribute Task Battery : Divided attention task |
10 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06326723 -
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT00001367 -
Diagnosis and History Study of Patients With Different Neurological Conditions
|
||
Completed |
NCT02699710 -
Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects
|
Phase 1 | |
Completed |
NCT02231892 -
Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
|
N/A | |
Not yet recruiting |
NCT06441916 -
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
|
Phase 1 | |
Completed |
NCT03771586 -
A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06337422 -
Bioequivalence Study of Generic Celecoxib 200 mg Capsules
|
Phase 1 | |
Completed |
NCT03302182 -
Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT05049343 -
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
|
Phase 1 | |
Recruiting |
NCT01629108 -
Normal Values in Hearing and Balance Testing
|
||
Completed |
NCT02947854 -
Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant
|
Phase 1 | |
Completed |
NCT02534870 -
Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT02224053 -
Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01676584 -
A Study of Single Dose RO6811135 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01697436 -
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
|
Phase 1 | |
Completed |
NCT01711762 -
A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT01684891 -
A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT01579149 -
A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent
|
Phase 1 | |
Completed |
NCT02547259 -
Influence of Emotion in a Test Run Forgetfulness
|
N/A | |
Completed |
NCT01591850 -
A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
|
Phase 1 |