Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP

February 17, 2024 updated by: Reem Mahmoud Gabr, Cairo University

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(

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, Cairo, Egypt
        • Clinical Neurophysiology unit- Kasr alainy-Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Out-patient epilepsy clinic at kasr alainy hopsital -Cairo University

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Group-1: Patients with TLE of both genders and aged > 18 years old
Diagnostic test: 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
Controls
Group-2: Age/gender matched healthy controls
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 minutes was the estimated test time. Outcome was assessed through study completion
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)
20 minutes was the estimated test time. Outcome was assessed through study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30-45 minutes is the estimated test time. Outcome was assessed through study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

November 25, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

February 10, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSR, HRV, QEEG in TLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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