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Objective EEG Bed Side Assessment of Impaired Conscious Awareness in Epilepsy

U

University Hospital Schleswig-Holstein (UKSH)

Status

Completed

Conditions

Epilepsy, Absence

Study type

Observational

Funder types

Other

Identifiers

NCT04799795
D 558/17

Details and patient eligibility

About

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.

Full 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)).

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

49 participants in 2 patient groups

healthy subjects
Description:
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.
patients with absence epilepsy
Description:
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.

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Inken Toedt, Dr. phil. Dipl.-Psych.; Helmut Laufs, PD Dr. med.

Data sourced from clinicaltrials.gov

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