Clinical trial NCT04799795: Objective EEG Bed Side Assessment of Impaired Conscious Awareness in Epilepsy
Official title: Objective EEG Bed Side Assessment of Impaired Conscious Awareness in Epilepsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy, Absence
Keywords: interictal activity
impaired consciousness
absence epilepsy
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2021-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed absence epilepsy at least 18 years old; age-matched controls.

Brief summary: In this project EEG recordings between healthy participants and those with a diagnosed Absence-epilepsy will be compared. The investigators suggest differences in EEG microstate analysis and neuropsychological parameters related to interictal cognitive impairment in these patients. This projects goal is to derive an EEG-based measure of conscious awareness.

Detailed description: This projects goal is to derive an EEG-based measure of conscious awareness to be applied in the care for epilepsy patients. The established terminology of "ictal" versus "interictal" is deceptive because it suggests that during the "interictal" phase epileptic activity is absent and detrimental mechanisms of the disease are only active during seizures. But evidence exists that cognitive impairment extends to states traditionally considered interictal. The development of an objective, ideally ambulatory test assessing cognitive impairment would not only provide a deeper understanding of the pathology but induce a change in clinical practice: if cognitive impairment could be demonstrated "interictally", this fact would help to weigh treatment effects against potential side-effects.

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)).

Eligibility criteria: Inclusion Criteria:

* age minimum 18 years
* diagnosis of (absence) epilepsy // healthy age-matched controls
* being of good health (besides epilepsy in the case group)

Exclusion Criteria:

* central nervous system disorders (besides epilepsy in the case group)
* substance abuse
* pregnancy

Primary outcomes:
measure: temporal integration changes according to different sleep states
timeFrame: 3 years
measure: temporal integration changes in interictal EEG
timeFrame: 3 years
measure: graph modularity changes according to different sleep states
timeFrame: 3 years
measure: graph modularity changes in interictal EEG
timeFrame: 3 years
Secondary outcomes:
measure: EEG based measures (Outcome 4) correlate with
timeFrame: 3 years
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department of Neurology
Study officials:
affiliation: University Hospital Schleswig-Holstein, Kiel
name: Inken Toedt, Dr. phil. Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Schleswig-Holstein, Kiel
name: Helmut Laufs, PD Dr. med.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.