Temporal Lobe EpilepsyNCT06269822
Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP
An observational study of Temporal Lobe Epilepsy, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporal Lobe Epilepsy
- What is being tested?
- Sympathetic skin response, heart rate variability test, quantitative EEG
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Out-patient epilepsy clinic at kasr alainy hopsital -Cairo University
Who may be able to join
- Patients diagnosed as temporal lobe epilepsy(TLE) depending on clinical semiology and EEG temporal inter-ictal epileptiform discharges
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Clinical Neurophysiology unit- Kasr alainy-Cairo University
Cairo, Cairo Governorate, Cairo, Egypt
About this study
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(
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.
Read the 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.
- Conditions
- Temporal Lobe Epilepsy
- Being tested
- Sympathetic skin response, heart rate variability test, quantitative EEG
- Keywords
- Temporal Lobe epilepsy (TLE), Sudden unexpected death of epileptic patients (SUDEP), Dysautonomia, Quantitative EEG (QEEG), Sympathetic Skin Response (SSR), Heart Rate Variability (HRV)
- Medical subject headings
- Epilepsy, Temporal Lobe, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sympathetic skin response, heart rate variability test, quantitative EEGDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Cases | Group-1: Patients with TLE of both genders and aged > 18 years old Receives: Diagnostic Test: Sympathetic skin response, heart rate variability test, quantitative EEG | |
| Controls | Group-2: Age/gender matched healthy controls Receives: Diagnostic Test: Sympathetic skin response, heart rate variability test, quantitative EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
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.
Measured: 30-45 minutes is the estimated test time. Outcome was assessed through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Sep 2022
- Primary completion25 Nov 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Temporal Lobe EpilepsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mahmoud Gabr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269822
- Sponsor's protocol ID
- SSR, HRV, QEEG in TLE
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36442376Barot 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.
PubMed 30456432Vieluf 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.
PubMed 31100658
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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(
- ClinicalTrials.gov ID
- NCT06269822
- Acronym / sponsor ID
- SSR, HRV, QEEG in TLE
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Sympathetic skin response, heart rate variability test, quantitative EEGGroup-1: Patients with TLE of both genders and aged > 18 years old |
| Controls | – | Diagnostic Test: Sympathetic skin response, heart rate variability test, quantitative EEGGroup-2: Age/gender matched healthy controls |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Out-patient epilepsy clinic at kasr alainy hopsital -Cairo University
Key inclusion criteria (1 listed)
- Patients diagnosed as temporal lobe epilepsy(TLE) depending on clinical semiology and EEG temporal inter-ictal epileptiform discharges
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sympathetic skin response, heart rate variability test, quantitative EEGSympathetic 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 | Diagnostic test | Cases, Controls |
Primary outcome
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)
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Background: PubMed 36442376Clemens 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.
- Background: PubMed 30456432Barot 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.
- Background: PubMed 31100658Vieluf 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.
- Individual participant dataSharing planned: Undecided
Related trials for Temporal Lobe Epilepsy
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
Epilepsy, Epilepsy, Temporal Lobe
Recruiting
Overnight TI in TLE
Temporal Lobe Epilepsy (TLE), Drug Resistant Epilepsy
RecruitingEarly Phase 1
Pharmacological Modulation of Brain Oscillations in Memory Processing
Epilepsy, Seizures
Not yet recruitingObservational study
Studying Heart Rhythms With a Wearable Sensor to Detect and Predict Seizures in People With Epilepsy
Epilepsy, Temporal Lobe, Drug Resistant Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporal Lobe Epilepsy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06269822, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.