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Trial record 18 of 1839 for:    epilepsy

Nucleotide Protein -3 in Epileptic Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04219930
Recruitment Status : Not yet recruiting
First Posted : January 7, 2020
Last Update Posted : January 9, 2020
Information provided by (Responsible Party):
Reham I El-mahdy, Assiut University

Brief Summary:

Epilepsy is one of common serious neurological malfunction, characterized by recurrent unprovoked seizures. It always accompanied with multitude of complications as cognitive, behavioral, and psychiatric disorders.

Experimental studies and clinical evidence obtained in animal models of epilepsy and human brain specimen from various drug-resistant forms of epilepsy show the activation of the innate and adaptive immunity mechanisms and the induction of the associated inflammatory processes in the epileptogenic foci.

Condition or disease Intervention/treatment
Epilepsy in Children Diagnostic Test: Expression of nucleotide protein -3

Detailed Description:

Epilepsy affects approximately 1% of the world population. Lifetime prevalence of childhood and adolescence epilepsy (children <18 years) in Upper Egypt was 9.7/1000, with higher prevalence among children <12 years (10.8/1000).

There is a clear cause for epilepsy in only a minority of the cases, while in up to70% of all case of epilepsy in adults and children, no cause can be discovered. Some of the main causes of epilepsy include: Low oxygen during birth, head injuries that occur during birth or from accidents during youth or adulthood, brain tumors, infections such as meningitis or encephalitis, stroke or any other type of damage to the brain.

A role of inflammatory molecules in the generation of seizures had been first investigated when selected anti-inflammatory treatments, in particular, steroids, immuno-globulins, and adrenocorticotropic hormone (ACTH), were shown to control seizures in pediatric epilepsies refractory to conventional anticonvulsive drugs. In addition, specific epileptic disorders have been associated with the presence of neuronal antigen-directed antibodies in plasma or cerebrospinal fluid (CSF).

A nucleotide-binding oligomerization domains (NODs) are cytosolic proteins that include key regulators of apoptosis and pathogen resistance in mammals and plants. A large number of NODs contain leucine-rich repeats (LRRs), hence referred to as NOD-LRR proteins. The NLRP3 gene provides instructions for making a protein called cryopyrin. Cryopyrin is a member of a family of proteins called nucleotide-binding domain and leucine-rich repeat containing (NLR) proteins. NLR family have two common features: the first is a nucleotide-binding oligomerization domain which is bound by ribonucleotide-phosphates (rNTP) and is important for self-oligomerization. The second is a C-terminal leucine-rich repeat, which serves as a ligand-recognition domain for other receptors (e.g. Toll like receptor (TLR)) or microbial ligands, while NLRP3 has been identified in microglial cells.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Biochemical Role of Nucleotide Protein -3 That Activate the Interleukin-1B in Epileptic Children
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
epileptic children
fifty patient with epilepsy
Diagnostic Test: Expression of nucleotide protein -3
Expression of nucleotide protein -3 will be measured in serum by ELISA

Healthy controls
thirty healthy control
Diagnostic Test: Expression of nucleotide protein -3
Expression of nucleotide protein -3 will be measured in serum by ELISA

Primary Outcome Measures :
  1. The mean difference of nucleotide protein -3 inflammatory marker expression in epileptic children and controls [ Time Frame: Baseline ]
    better understanding the role of inflammation in pathogenesis of epilepsy in children

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Epileptic children

Inclusion Criteria:

  • Epileptic children in Assiut university hospital, pediatric department, neurology unit.

Exclusion Criteria:

  • Children with other chronic disease such as liver, kidney or heart disease
  • patient who have apparent infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04219930

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Contact: reham elmahdy +201002714637

Sponsors and Collaborators
Assiut University

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Responsible Party: Reham I El-mahdy, Principal Investigator, Assiut University Identifier: NCT04219930    
Other Study ID Numbers: Epilepsy
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Reham I El-mahdy, Assiut University:
Interleukin B1
Nuclear Factor-Kappa B
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases