MiRNA223 and HMGB1 as Apredictos for Drug Resistant Epilepsy

October 16, 2022 updated by: Safaa Ali Samir Hussien Mohamed, Assiut University

Role of Plasma miRNA223 and High Mobility Group Box 1(HMGB1) as Predictors of Drug Resistant Epilepsy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Drug resistant epilepsy defined as(failure to achieve sustained seizure freedom after adequate and well tolerated trials of two anti-seizure medications) Well controlled epilepsy defined as(seizure freedom for at least the last 6months) matched in sex and age.

Description

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

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
role of estimation of serum level of miRNAs223 and HMGB1in detection of patient with drug resistant epilepsy.
Time Frame: 2year
Early detection of being drug resistant epilepsy might help in guiding patients for proper management and treatment strategy.
2year

Collaborators and Investigators

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

Sponsor

Assiut University

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)

November 1, 2022

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 16, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • drug resistant epilepsy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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Locations

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