Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP

Completed

• Conditions: Temporal Lobe Epilepsy
• Interventions: Diagnostic Test: Sympathetic skin response, heart rate variability test, quantitative EEG

• Registration Number: NCT06269822
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-11-25
• Study Completion: 2024-01-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-10
• Study First Submitted QC: 2024-02-17
• Last Update Submitted: 2024-02-17
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Sympathetic skin response, heart rate variability test, quantitative EEG	Group-2: Age/gender matched healthy controls
Cases	Sympathetic skin response, heart rate variability test, quantitative EEG	Group-1: Patients with TLE of both genders and aged \> 18 years old

Primary Outcome Measures

Name	Time	Method
Detection of autonomic dysfunction (Para-sympathetic domain) among cases of temporal lobe epilepsy	20 minutes was the estimated test time. Outcome was assessed through study completion	Evaluating the parasympathetic domain of the ANS using the heart rate variability test(HRV); in which root mean square of successive differences (RMSSD) as a time domain parameter was measured and then compared to the matched controls ( Reduced RMSSD denoting reduced vagal tone)
Detection of autonomic dysfunction (sympathetic domain) among cases of temporal lobe epilepsy	30 minutes was the estimated test time. Outcome was assessed through study completion	Assessing the sympathetic domain of the autonomic nervous system using sympathetic skin response (SSR) test; in which response latency and amplitude were measured and then compared to the matched controls (higher amplitude signifying higher sympathetic tone)

Secondary Outcome Measures

Name	Time	Method
Detection of the sudden unexpected death of epileptic patient (SUDEP) risk using Quantitative EEG (QEEG) in temporal lobe epilepsy(TLE) patients	30-45 minutes is the estimated test time. Outcome was assessed through study completion	Assessing of certain QEEG parameter could help in identifying patients with high SUDEP risk. SUDEP risk was evaluated using SUDEP-7 inventory score (7 questions each with 1 point); patients with higher score are assumed to have higher risk for developing sudden death.

Trial Locations

Locations (1)

Clinical Neurophysiology unit- Kasr alainy-Cairo University; 🇪🇬 Cairo, Cairo Governorate, Egypt