seizure: Inflammatory Biomarkers in Seizure

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05556109

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Biomarkers in Seizures	Diagnostic Test: Inflammatory serum biomarkers

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

Possible Role of Inflammatory Serum Biomarkers in Differentiation Between Epileptic Seizure and Psychogenic Non-epileptic Seizure

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Epileptic seizure patients diagnosed as epileptic seizure are aged >12 years	Diagnostic Test: Inflammatory serum biomarkers Measuring inflammatory serum biomarkers by ELISA
Psychogenic non-epileptic seizure patients diagnosed as psychogenic non-epileptic seizure are aged >12 years	Diagnostic Test: Inflammatory serum biomarkers 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	Diagnostic Test: Inflammatory serum biomarkers Measuring inflammatory serum biomarkers by ELISA

Arm

Intervention/Treatment

Epileptic seizure

patients diagnosed as epileptic seizure are aged >12 years

Diagnostic Test: Inflammatory serum biomarkers

Measuring inflammatory serum biomarkers by ELISA

Psychogenic non-epileptic seizure

patients diagnosed as psychogenic non-epileptic seizure are aged >12 years

Diagnostic Test: Inflammatory serum biomarkers

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

Diagnostic Test: Inflammatory serum biomarkers

Measuring inflammatory serum biomarkers by ELISA

Outcome Measures

Primary Outcome Measures

Detection of the level of inflammatory biomarkers in epileptic seizure and psychogenic non-epileptic seizure [2 years]
Evaluation of the role of TRAIL and MCP-2 in differentiation between epileptic seizure and psychogenic non-epileptic seizure

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Esraa Mostafa Ahmed Abdel Aal, Doctor, Assiut University

ClinicalTrials.gov Identifier:

NCT05556109

Other Study ID Numbers:

Biomarkers in seiz

First Posted:

Sep 27, 2022

Last Update Posted:

Sep 27, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Seizures

Study Results

No Results Posted as of Sep 27, 2022