Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP

Temporal Lobe Epilepsy Clinical Trial

Official 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(

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06269822
• Other study ID #: SSR, HRV, QEEG in TLE
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 1, 2024
• Est. primary completion date: November 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Epilepsy
• Epilepsy, Temporal Lobe
• Primary Dysautonomias
• Temporal Lobe Epilepsy

Intervention

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

Locations

Country	Name	City	State
Egypt	Clinical Neurophysiology unit- Kasr alainy-Cairo University	Cairo	Cairo Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Detection of the sudden unexpected death of epileptic patient (SUDEP) risk using Quantitative EEG (QEEG) in temporal lobe epilepsy(TLE) patients	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