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(
Verified date | February 2024 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Clinical Neurophysiology unit- Kasr alainy-Cairo University | Cairo | Cairo Governorate |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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
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 |
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