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Completed

NCT Number: NCT06269822

Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP

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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Key information

Conditions

Temporal Lobe Epilepsy Autonomic Nervous System Diseases Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Epilepsy, Temporal Lobe Epileptic Syndromes Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Neurophysiology unit- Kasr alainy-Cairo University

Cairo, Cairo Governorate, Cairo, Egypt, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sympathetic skin response, heart rate variability test, quantitative EEG

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

Primary outcomes

  1. Detection of autonomic dysfunction (sympathetic domain) among cases of temporal lobe epilepsy

    Time frame: 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)

  2. Detection of autonomic dysfunction (Para-sympathetic domain) among cases of temporal lobe epilepsy

    Time frame: 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)

Secondary outcomes

  1. Detection of the sudden unexpected death of epileptic patient (SUDEP) risk using Quantitative EEG (QEEG) in temporal lobe epilepsy(TLE) patients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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(

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2024
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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