Objective EEG Bed Side Assessment of Impaired Conscious Awareness in Epilepsy

Epilepsy, Absence Clinical Trial

Official title:

Objective EEG Bed Side Assessment of Impaired Conscious Awareness in Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799795
• Other study ID #: D 558/17
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University Hospital Schleswig-Holstein
• Contact: Inken Toedt, Dr. phil. Dipl.-Psych.
• Phone: 0049 431 500 23985
• Email: inken.toedt[@]uksh.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Absence

Locations

Country	Name	City	State
Germany	Department of Neurology	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	temporal integration changes according to different sleep states	The investigators develop an EEG-based measure of impaired conscious awareness based on wakefulness and deepening sleep stages which will serve as a model for increasingly impaired conscious awareness. By performing a microstate analysis on EEG data, the investigators hypothesize a decrease of the temporal integration, a prerequisite for conscious awareness, of the EEG gradually from wakefulness to deep sleep.	3 years
Primary	temporal integration changes in interictal EEG	The investigators apply the aforementioned analysis (leading to Outcome 1) on interictal EEG recordings obtained from patients with diagnosed absence epilepsy. The investigators hypothesize a reduced temporal integration in epilepsies with reduced consciousness.	3 years
Primary	graph modularity changes according to different sleep states	The investigators will calculate the EEG-based functional connectivity and graph modularity for each sleep state. The investigators hypothesize that during wakefulness, graph modularity will be lower than during the descent to sleep.	3 years
Primary	graph modularity changes in interictal EEG	The investigators will calculate the EEG-based functional connectivity and graph modularity for the absence epilepsy condition. The investigators hypothesize that impaired consciousness will be reflected in lower graph modularity compared to healthy subjects.	3 years
Secondary	EEG based measures (Outcome 4) correlate with	The investigators hypothesize that the graph modularity level correlates with neuropsychological test scores in the surveyed data of epilepsy patients.	3 years