MiRNA223 and HMGB1 as Apredictos for Drug Resistant Epilepsy

NCT ID: NCT05555537

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-11-01

Brief Summary

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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.

Detailed Description

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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) .

Conditions

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Drug Resistant Epilepsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Drug resistant epilepsy

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

MiRNA223 and High mobility group box1(HMGB1)

Intervention Type DIAGNOSTIC_TEST

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.

MiRNA223 and High mobility group box1(HMGB1)

Intervention Type DIAGNOSTIC_TEST

Measure tye 2 biomarkers miRNA223 and HMGB1 in drug resistant and in medically controled epilepsy

Interventions

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MiRNA223 and High mobility group box1(HMGB1)

Measure tye 2 biomarkers miRNA223 and HMGB1 in drug resistant and in medically controled epilepsy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Safaa Ali Samir Hussien Mohamed

Assistant lecture

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Safaa Ali Ali, Assistant lecture

Role: CONTACT

01018612254

Safaa Ali, Assistant

Role: CONTACT

01018612254

Other Identifiers

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drug resistant epilepsy

Identifier Type: -

Identifier Source: org_study_id

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