Clinical trial NCT06269822: Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP
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(
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporal Lobe Epilepsy
Keywords: Temporal Lobe epilepsy (TLE)
Sudden unexpected death of epileptic patients (SUDEP)
Dysautonomia
Quantitative EEG (QEEG)
Sympathetic Skin Response (SSR)
Heart Rate Variability (HRV)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out-patient epilepsy clinic at kasr alainy hopsital -Cairo University

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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as temporal lobe epilepsy(TLE) depending on clinical semiology and EEG temporal inter-ictal epileptiform discharges

Exclusion Criteria:

* Any identifiable disease that could affect autonomic nervous system function including diabetic patients.
* Any drug that could affect autonomic nervous system function including oral contraceptives

Primary outcomes:
measure: Detection of autonomic dysfunction (sympathetic domain) among cases of temporal lobe epilepsy
timeFrame: 30 minutes was the estimated test time. Outcome was assessed through study completion
measure: Detection of autonomic dysfunction (Para-sympathetic domain) among cases of temporal lobe epilepsy
timeFrame: 20 minutes was the estimated test time. Outcome was assessed through study completion
Secondary outcomes:
measure: Detection of the sudden unexpected death of epileptic patient (SUDEP) risk using Quantitative EEG (QEEG) in temporal lobe epilepsy(TLE) patients
timeFrame: 30-45 minutes is the estimated test time. Outcome was assessed through study completion
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Clinical Neurophysiology unit- Kasr alainy-Cairo University
state: Cairo Governorate
Study officials:
References:
citation: Clemens B, Emri M, Fekete I, Fekete K. Epileptic diathesis: An EEG-LORETA study. Clin Neurophysiol. 2023 Jan;145:54-61. doi: 10.1016/j.clinph.2022.11.004. Epub 2022 Nov 17.
citation: Barot N, Nei M. Autonomic aspects of sudden unexpected death in epilepsy (SUDEP). Clin Auton Res. 2019 Apr;29(2):151-160. doi: 10.1007/s10286-018-0576-1. Epub 2018 Nov 19.
citation: Vieluf S, El Atrache R, Hammond S, Touserkani FM, Loddenkemper T, Reinsberger C. Peripheral multimodal monitoring of ANS changes related to epilepsy. Epilepsy Behav. 2019 Jul;96:69-79. doi: 10.1016/j.yebeh.2019.02.018. Epub 2019 May 14.