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(
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Detection of autonomic dysfunction (Para-sympathetic domain) among cases of temporal lobe epilepsy
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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)
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)
Secondary Outcomes
- 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)
Investigators
Reem Mahmoud Gabr
doctor
Cairo University