- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05556109
Inflammatory Biomarkers in Seizure (seizure)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Epileptic seizure
patients diagnosed as epileptic seizure are aged >12 years
|
Measuring inflammatory serum biomarkers by ELISA
|
|
Psychogenic non-epileptic seizure
patients diagnosed as psychogenic non-epileptic seizure are aged >12 years
|
Measuring inflammatory serum biomarkers by ELISA
|
|
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
|
Measuring inflammatory serum biomarkers by ELISA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Biomarkers in seiz
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.