Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799795
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2021-03-12
Brief Title:
Objective EEG Bed Side Assessment of Impaired Conscious Awareness in Epilepsy
Sponsor:
University Hospital Schleswig-Holstein
Organization:
University Hospital Schleswig-Holstein
Study Overview
Official Title:
Objective EEG Bed Side Assessment of Impaired Conscious Awareness in Epilepsy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None