Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP

NCT06269822 | Completed

• 1 other identifier: SSR, HRV, QEEG in TLE
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (1)

• 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

Study Arms (2)

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

Controls

Group-2: Age/gender matched healthy controls

Diagnostic Test: Sympathetic skin response, heart rate variability test, quantitative EEG

Interventions

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

Cases; Controls

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Clinical Neurophysiology unit- Kasr alainy-Cairo University

Cairo, Cairo Governorate, Cairo, Egypt, Egypt

Location

Related Publications (3)

• 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.

  PMID: 36442376 BACKGROUND

• 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.

  PMID: 30456432 BACKGROUND

• 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.

  PMID: 31100658 BACKGROUND

MeSH Terms

Conditions

Epilepsy, Temporal Lobe; Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: February 10, 2024
• First Posted: February 21, 2024
• Study Start: September 1, 2022
• Primary Completion: November 25, 2023
• Study Completion: January 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

EG (1)