Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06269822
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2024-02-10
Brief Title:
Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Electrophysiological Evaluation of Autonomic Dysfunction in Persons With Temporal Lobe Epilepsy and Its Relation Ship With Sudden Unexpected Death of Epileptic Patient SUDEP Risk Development
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The study aimed at detection of autonomic dysfunction among cases with temporal lobe epilepsy using different electrophysiological techniques
Moreover it aimed at finding any correlation between electrophysiological tests and SUDEP risk
Moreover it aimed at finding any correlation between electrophysiological tests and SUDEP risk
Detailed Description:
Temporal lobe epilepsy TLE is the commonest focal form of epilepsy representing 60 of all epilepsies It has two major subtypes neocortical nTLE and mesial mTLE each with different presentations
Its diagnosis depends on detailed clinical history neurological examination as well as neurophysiological including EEG and neuroimaging diagnostic tests which are mandatory in localizing the pathology
Intimate connection between epileptic networks and the autonomic nervous system had been revealed Seizures could affect autonomic functions whether directly through activation of cortical autonomic centers or indirectly through the released catecholamines
The SUDEP is considered as one of the most serious complications of epilepsy and second most common cause of death from neurological diseases after stroke Autonomic dysfunction could have a potential role in the pathophysiology of sudden unexpected death of epileptic patients SUDEP
Attention has been focused on biomarkers that could assist in the detection and early stratification of SUDEP risk Such biomarkers include neurophysiological tests imaging findings laboratory findings
Among the introduced neurophysiological biomarkers are electroencephalogram EEG sympathetic skin response SSR and heart rate variability HRV
The HRV is considered as simple sensitive index of cardiovagal function Reduced heart rate variability HRV is a strong predictor of sudden death in patients with heart disease
The electrodermal activity EDA or SSR is referred as the most popular used test for assessment the sudomotor function The EDA had been proven to be a reliable biomarker for detecting generalized tonic-clonic seizures GTCs through a wearable device
Frontal midline theta activity was studied using quantitative EEG QEEG that confirmed the presence of interactive relationships between activities of the peripheral autonomic system and the cortical network The QEEG technique had been introduced in the thirties of the last century Yet it had not been applied before on epileptic patients to assess either the central autonomic function or the SUDEP risk and thus this is considered as the first study to address such issue
Its diagnosis depends on detailed clinical history neurological examination as well as neurophysiological including EEG and neuroimaging diagnostic tests which are mandatory in localizing the pathology
Intimate connection between epileptic networks and the autonomic nervous system had been revealed Seizures could affect autonomic functions whether directly through activation of cortical autonomic centers or indirectly through the released catecholamines
The SUDEP is considered as one of the most serious complications of epilepsy and second most common cause of death from neurological diseases after stroke Autonomic dysfunction could have a potential role in the pathophysiology of sudden unexpected death of epileptic patients SUDEP
Attention has been focused on biomarkers that could assist in the detection and early stratification of SUDEP risk Such biomarkers include neurophysiological tests imaging findings laboratory findings
Among the introduced neurophysiological biomarkers are electroencephalogram EEG sympathetic skin response SSR and heart rate variability HRV
The HRV is considered as simple sensitive index of cardiovagal function Reduced heart rate variability HRV is a strong predictor of sudden death in patients with heart disease
The electrodermal activity EDA or SSR is referred as the most popular used test for assessment the sudomotor function The EDA had been proven to be a reliable biomarker for detecting generalized tonic-clonic seizures GTCs through a wearable device
Frontal midline theta activity was studied using quantitative EEG QEEG that confirmed the presence of interactive relationships between activities of the peripheral autonomic system and the cortical network The QEEG technique had been introduced in the thirties of the last century Yet it had not been applied before on epileptic patients to assess either the central autonomic function or the SUDEP risk and thus this is considered as the first study to address such issue
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