Inflammatory Biomarkers in Psychogenic Non-epileptic Seizure (seizure)

October 4, 2022 updated by: Esraa Mostafa Ahmed Abdel Aal

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

  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.

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Epileptic seizure
Measuring inflammatory serum biomarkers in epileptic seizure patients and psychogenic non-epileptic seizure
Other: Measuring inflammatory serum biomarkers
Measuring inflammatory serum biomarkers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1- Evaluation of the role of TRAIL and MCP-2 in differentiation between epileptic seizure and psychogenic non-epileptic seizure
Time Frame: in first 24 hours of seizure
Measurement of TRAIL and MCP-2 in differentiation between epileptic seizure and psychogenic non-epileptic seizure.
in first 24 hours of seizure
2- Possible role to predict the prognosis of patients with epileptic seizure.
Time Frame: in first 24 hours of seizure
Differentiation between epileptic seizure and psychogenic non-epileptic seizure help in diagnosis and predict prognosis of seizure
in first 24 hours of seizure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esraa Mostafa Ahmed Abdel Aal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Serum biomarkers in seiz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Localization-Related (Focal) (Partial) Idiopathic Epilepsy and Epileptic Syndromes With Seizures of Localized Onset

Clinical Trials on Measuring inflammatory serum biomarkers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe