Biomarkers in SeizuresseizureNCT05556109
Inflammatory Biomarkers in Seizure
An observational study of Biomarkers in Seizures, run by Assiut University.
Trial summary
1. Evaluation of the role of TRAIL and MCP-2 in differentiation between epileptic seizure and psychogenic non-epileptic seizure. 2. Possible role to predict the prognosis of patients with epileptic seizure Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Biomarkers in Seizures
- What is being tested?
- Inflammatory serum biomarkers
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Nov 2024
- How long will I take part?
- 1 Day
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients diagnosed as epileptic seizure are aged >12 years patients diagnosed as psychogenic non-epileptic seizure are aged >12 years Normal healthy control for comparison. Heathy control are aged >12 years with no history of lifetime seizures or suspected seizures or febrile seizure and no treatment with an antiepileptic drug (AED) prior to blood draw
Who may be able to join
- patients diagnosed as epileptic seizure are aged >12 years patients diagnosed as psychogenic non-epileptic seizure are aged >12 years Normal healthy control for comparison. Heathy control are aged >12 years with no history of lifetime seizures or suspected seizures or febrile seizure and no treatment with an antiepileptic drug (AED) prior to blood draw
Who cannot join
- Neurological criteria: Other CNS disorders including Parkinson's disease, amyotrophic lateral sclerosis ,cerebrovascular stroke, Psychiatric disorders {major depression disorder , generalized anxiety, mania and other psychiatric diseases).
- Others: Tumors and cardiovascular
About this study
Official title: Possible Role of Inflammatory Serum Biomarkers in Differentiation Between Epileptic Seizure and Psychogenic Non-epileptic Seizure
- Evaluation of the role of TRAIL and MCP-2 in differentiation between epileptic seizure and psychogenic non-epileptic seizure.
- Possible role to predict the prognosis of patients with epileptic seizure
Read the detailed description
Epilepsy is one of the most prevalent neurological disorders characterized by frequent somatic and psychiatric co-morbidities(1). Accurate diagnosis of epilepsy is challenging because clinicians rarely observe the actual clinical seizure outside of the hospital. Furthermore, psychogenic nonepileptic seizures (PNES) can mimic epileptic seizures (ES), leading to erroneous diagnosis and inappropriate treatments. A critical gap in the diagnostic assessment of seizures is a blood test that can distinguish ES from PNES (2). Both diagnoses were confirmed by the gold standard diagnostic method video/electroencephalogram (EEG) monitoring (3). Taking all in to account, the notion that neuro-inflammation is the key pathology behind focal epileptic seizure initiation and maintenance and the dynamic and adaptative process of neuro -inflammation is associated with blood-brain-barrier disruption and glial activation is no longer a surprise (4).
Tumor necrosis factor related apoptosis inducing ligand (TRAIL) regulates immune responses via apoptosis, with lower levels associated with severe infection, including sepsis (5). Monocyte chemoattractant protein-2 (MCP-2) has been well recognized to participate in immune regulation via binding to chemokine receptors and activation chemotaxis in lymphocytes T, natural killer (NK) cells, and monocytes therefore contributing to the pathogenesis of monocyte-dependent tissue injury (6). Hence, MCP-2 overexpression could result in an increased immune response. Further, since increased levels of MCP-2 have been observed in patients with Alzheimer's disease, this may further support the existence of the biodirections relationship between neurodegeneration and seizures/epilepsy (7).
- Conditions
- Biomarkers in Seizures
- Being tested
- Inflammatory serum biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammatory serum biomarkersDiagnostic test
Measuring inflammatory serum biomarkers by ELISA
| Study group | Role | What they receive |
|---|---|---|
| Epileptic seizure | patients diagnosed as epileptic seizure are aged >12 years Receives: Diagnostic Test: Inflammatory serum biomarkers | |
| Psychogenic non-epileptic seizure | patients diagnosed as psychogenic non-epileptic seizure are aged >12 years Receives: Diagnostic Test: Inflammatory serum biomarkers | |
| Normal healthy control | Heathy control are aged >12 years with no history of lifetime seizures or suspected seizures or febrile seizure and no treatment with an antiepileptic drug (AED) prior to blood draw Receives: Diagnostic Test: Inflammatory serum biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of the level of inflammatory biomarkers in epileptic seizure and psychogenic non-epileptic seizure
Evaluation of the role of TRAIL and MCP-2 in differentiation between epileptic seizure and psychogenic non-epileptic seizure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomarkers in SeizuresStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mostafa Ahmed Abdel Aal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556109
- Sponsor's protocol ID
- Biomarkers in seiz
- Acronym
- seizure
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Role of Inflammatory Serum Biomarkers in Differentiation Between Epileptic Seizure and Psychogenic Non-epileptic Seizure
- ClinicalTrials.gov ID
- NCT05556109
- Acronym / sponsor ID
- seizure / Biomarkers in seiz
- Conditions
- Biomarkers in Seizures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 27 Sep 2022 (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.
- Evaluation of the role of TRAIL and MCP-2 in differentiation between epileptic seizure and psychogenic non-epileptic seizure.
- Possible role to predict the prognosis of patients with epileptic seizure
Detailed description
Epilepsy is one of the most prevalent neurological disorders characterized by frequent somatic and psychiatric co-morbidities(1). Accurate diagnosis of epilepsy is challenging because clinicians rarely observe the actual clinical seizure outside of the hospital. Furthermore, psychogenic nonepileptic seizures (PNES) can mimic epileptic seizures (ES), leading to erroneous diagnosis and inappropriate treatments. A critical gap in the diagnostic assessment of seizures is a blood test that can distinguish ES from PNES (2). Both diagnoses were confirmed by the gold standard diagnostic method video/electroencephalogram (EEG) monitoring (3). Taking all in to account, the notion that neuro-inflammation is the key pathology behind focal epileptic seizure initiation and maintenance and the dynamic and adaptative process of neuro -inflammation is associated with blood-brain-barrier disruption and glial activation is no longer a surprise (4).
Tumor necrosis factor related apoptosis inducing ligand (TRAIL) regulates immune responses via apoptosis, with lower levels associated with severe infection, including sepsis (5). Monocyte chemoattractant protein-2 (MCP-2) has been well recognized to participate in immune regulation via binding to chemokine receptors and activation chemotaxis in lymphocytes T, natural killer (NK) cells, and monocytes therefore contributing to the pathogenesis of monocyte-dependent tissue injury (6). Hence, MCP-2 overexpression could result in an increased immune response. Further, since increased levels of MCP-2 have been observed in patients with Alzheimer's disease, this may further support the existence of the biodirections relationship between neurodegeneration and seizures/epilepsy (7).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epileptic seizure | – | Diagnostic Test: Inflammatory serum biomarkerspatients diagnosed as epileptic seizure are aged >12 years |
| Psychogenic non-epileptic seizure | – | Diagnostic Test: Inflammatory serum biomarkerspatients diagnosed as psychogenic non-epileptic seizure are aged >12 years |
| Normal healthy control | – | Diagnostic Test: Inflammatory serum biomarkersHeathy control are aged >12 years with no history of lifetime seizures or suspected seizures or febrile seizure and no treatment with an antiepileptic drug (AED) prior to blood draw |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients diagnosed as epileptic seizure are aged >12 years patients diagnosed as psychogenic non-epileptic seizure are aged >12 years Normal healthy control for comparison. Heathy control are aged >12 years with no history of lifetime seizures or suspected seizures or febrile seizure and no treatment with an antiepileptic drug (AED) prior to blood draw
Key inclusion criteria (1 listed)
- patients diagnosed as epileptic seizure are aged >12 years patients diagnosed as psychogenic non-epileptic seizure are aged >12 years Normal healthy control for comparison. Heathy control are aged >12 years with no history of lifetime seizures or suspected seizures or febrile seizure and no treatment with an antiepileptic drug (AED) prior to blood draw
Key exclusion criteria (2 listed)
- Neurological criteria: Other CNS disorders including Parkinson's disease, amyotrophic lateral sclerosis ,cerebrovascular stroke, Psychiatric disorders {major depression disorder , generalized anxiety, mania and other psychiatric diseases).
- Others: Tumors and cardiovascular
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 |
|---|---|---|
| Inflammatory serum biomarkersMeasuring inflammatory serum biomarkers by ELISA | Diagnostic test | Epileptic seizure, Normal healthy control, Psychogenic non-epileptic seizure |
Primary outcome
Detection of the level of inflammatory biomarkers in epileptic seizure and psychogenic non-epileptic seizure
Time frame: 2 years
Evaluation of the role of TRAIL and MCP-2 in differentiation between epileptic seizure and psychogenic non-epileptic seizure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarkers in Seizures, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 the level of inflammatory biomarkers in epileptic seizure and psychogenic non-epileptic seizure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2022.