Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Temporal Lobe Epilepsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Cases

Group-1: Patients with TLE of both genders and aged \> 18 years old

Sympathetic skin response, heart rate variability test, quantitative EEG

Intervention Type DIAGNOSTIC_TEST

Sympathetic skin test (electrodermal activity) to test for sympathetic function Heart rate variability test to assess cardiovagal function Quantitative EEG to quantitatively assessing the brain function using fast fourier transform technique

Controls

Group-2: Age/gender matched healthy controls

Sympathetic skin response, heart rate variability test, quantitative EEG

Intervention Type DIAGNOSTIC_TEST

Sympathetic skin test (electrodermal activity) to test for sympathetic function Heart rate variability test to assess cardiovagal function Quantitative EEG to quantitatively assessing the brain function using fast fourier transform technique

Interventions

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Sympathetic skin response, heart rate variability test, quantitative EEG

Sympathetic skin test (electrodermal activity) to test for sympathetic function Heart rate variability test to assess cardiovagal function Quantitative EEG to quantitatively assessing the brain function using fast fourier transform technique

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes