Objective EEG Bed Side Assessment of Impaired Conscious Awareness in Epilepsy
NCT ID: NCT04799795
Last Updated: 2025-07-08
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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COMPLETED
49 participants
OBSERVATIONAL
2021-10-01
2025-05-24
Brief Summary
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Detailed Description
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In this project the investigators will set out to
1. identify EEG markers in healthy volunteers, which reflect the changes in spatial and temporal dynamics of neuronal activity during states of reduced conscious awareness using sleep as an example of a state of reduced conscious awareness;
2. assess with neuropsychological testing reductions in interictal conscious awareness in patients with epilepsy;
3. test, whether markers established under (1) are valid in individuals with epilepsy and interictally reduced conscious awareness (see (2)).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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healthy subjects
Age-matched healthy participants will be recruited via flyers at public education facilities and online advertisement. Participants need to be healthy and without central nervous system disorders and substance abuse. The investigators will also exclude pregnant women from the experiment.
No interventions assigned to this group
patients with absence epilepsy
Apart from the diagnosis of epilepsy, patients need to be of good health and without central nervous system disorders and substance abuse. The investigators will also exclude pregnant women from the experiment.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* diagnosis of (absence) epilepsy // healthy age-matched controls
* being of good health (besides epilepsy in the case group)
Exclusion Criteria
* substance abuse
* pregnancy
18 Years
ALL
Yes
Sponsors
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German Research Foundation
OTHER
University Hospital Schleswig-Holstein
OTHER
Responsible Party
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Gesine Hermann, MD
Scientist in Neuroimaging
Principal Investigators
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Inken Toedt, Dr. phil. Dipl.-Psych.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Schleswig-Holstein, Kiel
Helmut Laufs, PD Dr. med.
Role: STUDY_DIRECTOR
University Hospital Schleswig-Holstein, Kiel
Locations
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Department of Neurology
Kiel, , Germany
Countries
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References
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Brodbeck V, Kuhn A, von Wegner F, Morzelewski A, Tagliazucchi E, Borisov S, Michel CM, Laufs H. EEG microstates of wakefulness and NREM sleep. Neuroimage. 2012 Sep;62(3):2129-39. doi: 10.1016/j.neuroimage.2012.05.060. Epub 2012 May 30.
Haimovici A, Tagliazucchi E, Balenzuela P, Laufs H. On wakefulness fluctuations as a source of BOLD functional connectivity dynamics. Sci Rep. 2017 Jul 19;7(1):5908. doi: 10.1038/s41598-017-06389-4.
Kuhn A, Brodbeck V, Tagliazucchi E, Morzelewski A, von Wegner F, Laufs H. Narcoleptic Patients Show Fragmented EEG-Microstructure During Early NREM Sleep. Brain Topogr. 2015 Jul;28(4):619-35. doi: 10.1007/s10548-014-0387-1. Epub 2014 Aug 29.
Laufs H, Rodionov R, Thornton R, Duncan JS, Lemieux L, Tagliazucchi E. Altered FMRI connectivity dynamics in temporal lobe epilepsy might explain seizure semiology. Front Neurol. 2014 Sep 11;5:175. doi: 10.3389/fneur.2014.00175. eCollection 2014.
Tagliazucchi E, Crossley N, Bullmore ET, Laufs H. Deep sleep divides the cortex into opposite modes of anatomical-functional coupling. Brain Struct Funct. 2016 Nov;221(8):4221-4234. doi: 10.1007/s00429-015-1162-0. Epub 2015 Dec 9.
Tagliazucchi E, Laufs H. Decoding wakefulness levels from typical fMRI resting-state data reveals reliable drifts between wakefulness and sleep. Neuron. 2014 May 7;82(3):695-708. doi: 10.1016/j.neuron.2014.03.020.
Tagliazucchi E, Roseman L, Kaelen M, Orban C, Muthukumaraswamy SD, Murphy K, Laufs H, Leech R, McGonigle J, Crossley N, Bullmore E, Williams T, Bolstridge M, Feilding A, Nutt DJ, Carhart-Harris R. Increased Global Functional Connectivity Correlates with LSD-Induced Ego Dissolution. Curr Biol. 2016 Apr 25;26(8):1043-50. doi: 10.1016/j.cub.2016.02.010. Epub 2016 Apr 13.
Tagliazucchi E, von Wegner F, Morzelewski A, Brodbeck V, Borisov S, Jahnke K, Laufs H. Large-scale brain functional modularity is reflected in slow electroencephalographic rhythms across the human non-rapid eye movement sleep cycle. Neuroimage. 2013 Apr 15;70:327-39. doi: 10.1016/j.neuroimage.2012.12.073. Epub 2013 Jan 9.
Tagliazucchi E, von Wegner F, Morzelewski A, Brodbeck V, Jahnke K, Laufs H. Breakdown of long-range temporal dependence in default mode and attention networks during deep sleep. Proc Natl Acad Sci U S A. 2013 Sep 17;110(38):15419-24. doi: 10.1073/pnas.1312848110. Epub 2013 Sep 3.
von Wegner F, Tagliazucchi E, Laufs H. Information-theoretical analysis of resting state EEG microstate sequences - non-Markovianity, non-stationarity and periodicities. Neuroimage. 2017 Sep;158:99-111. doi: 10.1016/j.neuroimage.2017.06.062. Epub 2017 Jun 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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D 558/17
Identifier Type: -
Identifier Source: org_study_id
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