MiRNA223 and HMGB1 as Apredictos for Drug Resistant Epilepsy

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05555537
Collaborator
(none)
90
24

Study Details

Study Description

Brief Summary

Evaluation of the role of estimation of serum level of miRNAs223 and HMGB1in detection of patient with drug resistant epilepsy.

Early detection of the prognosis might help in guiding patients for proper management and treatment strategy.

This may open the door for new drug trials.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MiRNA223 and High mobility group box1(HMGB1)

Detailed Description

Epilepsy is the most prevalent neurological disorders (1). Drug-resistant epilepsy (DRE) represent approximately 30% of epilepsy..DRE is defined as failure to achieve sustained seizure freedom after adequate and well tolerated trials of two antiseizure medications( ASMs).The identification of circulating biomarkers for DRE could give an early idea about the prognosis and improve the choice of correct treatment.

MiRNAs are small noncoding RNAs that span between 19 and 24 nucleotide bases((2).They gain biological activity through base pairing in the 30-untranslated regions of target messenger RNA (mRNA) , thereby guiding a protein complex termed the RNA-induced silencing complex (RISC) that bind to the mRNA sequence and results in either the inhibition of translational processes or the degradation of the mRNA (3). Dysregulated miRNA expression has been associated with inflammatory pathways, cell death, neuronal excitability, and synaptic reorganization, which underlie epileptogenesis (4).

High- mobility group box 1(HMGB1) is a chromatin component that is physiologically attached to nuclei. However, following CNS insult, it can promptly be migrated towards cytoplasm and is discharged extracellularly. HMGB1mediates sterile neuro-inflammation evoked by epileptogenic injury and recurrent seizures(5) .HMGB1 increases in neurons, glia, and endothelial cells of the blood brain barrier (BBB) in DRE.

The HMGB1 contributes to the overexpression of P-glycoprotein, a BBB protein, which is induced in DRE foci and extrudes various ASMs from the brain(6) .

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Role of Plasma miRNA223 and High Mobility Group Box 1(HMGB1) as Predictors of Drug Resistant Epilepsy
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Drug resistant epilepsy

failure to achieve sustained seizure freedom after adequate and well tolerated trials of two antiseizure medications

Diagnostic Test: MiRNA223 and High mobility group box1(HMGB1)
Measure tye 2 biomarkers miRNA223 and HMGB1 in drug resistant and in medically controled epilepsy

Medically controled epilepsy

seizure freedom for at least the last 6months) matched in sex and age.

Diagnostic Test: MiRNA223 and High mobility group box1(HMGB1)
Measure tye 2 biomarkers miRNA223 and HMGB1 in drug resistant and in medically controled epilepsy

Outcome Measures

Primary Outcome Measures

  1. role of estimation of serum level of miRNAs223 and HMGB1in detection of patient with drug resistant epilepsy. [2year]

    Early detection of being drug resistant epilepsy might help in guiding patients for proper management and treatment strategy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients diagnosed as drug resistant epilepsy .

  • Control group: patients diagnosed as medically controlled epilepsy

Exclusion Criteria:
  • Symptomatic epilepsy (vascular, tumor, post encephalitic, syndromic and febrile seizures).

  • Alzheimers disease

  • Parkinsons disease

  • amyotrophic lateral sclerosis

  • major depression disorder

  • Non neurological criteria: 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:
Safaa Ali Samir Hussien Mohamed, Assistant lecture, Assiut University
ClinicalTrials.gov Identifier:
NCT05555537
Other Study ID Numbers:
  • drug resistant epilepsy
First Posted:
Sep 27, 2022
Last Update Posted:
Oct 18, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2022