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NCT Number: NCT06665880

Genes, Proteins, and Metabolites in Drug-resistant Epilepsy (DRE) Patients

In patients with drug-resistant epilepsy (DRE), there may be changes at the genetic, proteomic, and metabolomic levels when comparing epileptic tissues from DRE to normal tissues in traumatic brain injury (TBI). These changes could help in understanding the pathophysiological mechanisms of epilepsy and in identifying new therapeutic targets.

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Key information

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Genomical studies have identified changes in the expression of certain genes within epileptic tissues. These genes may be involved in pathways related to the balance of neuronal excitability and inhibition, synaptic transmission, and cell apoptosis.

Proteomic studies will reveal changes in the abundance and modifications of proteins in epileptic tissues. These could involve proteins related to the control of neuronal excitability and synaptic transmission, such as ion channels, neurotransmitter receptors, and synaptic proteins.

Metabolomic researches will reveal changes in metabolites within epileptic tissues. Epilepsy may lead to disruptions in metabolic pathways, affecting key processes such as energy metabolism, amino acid metabolism, and lipid metabolism.

Sample Size: There is no minimum or maximum, but is expected to be far less than 10.

In summary, patients with drug-resistant epilepsy might have changes in genes, proteomics, and metabolomics within epileptic tissues compared to normal tissue from TBI. Further research into these changes will deepen our understanding of the pathophysiology of epilepsy and guide the need for new treatment strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 14-60 years old, male or female, Han Chinese;
  • Drug-resistant epilepsy;
  • Required surgical implantation of SEEG electrodes.

Exclusion criteria

  • Progressive encephalopathy or progressive structural damage in the central nervous system;
  • Significant heart, liver, renal insufficiency, and other medical diseases;
  • Severe side effects from taking antiepileptic drugs at the time of enrollment and not inappropriate for SEEG;
  • Significant intellectual disability;
  • A history of alcohol and drug abuse;
  • Any contraindication to MRI.

Treatment and study plan

Routine clinical treatment

Other

Routine clinical treatment is based on the latest international guidelines for DRE.

Primary outcomes

  1. Single cell RNA sequencing

    Time frame: through study completion, an average of one year

    Cancerous and paracancerous tissues of patients will be subjected to10x Genomics single-cell RNA sequencing, Bulk RNA-seq and spatial transcriptome.

Secondary outcomes

  1. Differentially expressed proteins

    Time frame: through study completion, an average of one year

    Discovering differentially expressed proteins (DEPs) and their roles in DRE patients, we will conduct 4D-DIA quantitative proteomics analysis.

  2. The concentration of metabolites

    Time frame: through study completion, an average of one year

    Metabolites of cancerous and paracancerous tissues in patients will be subjected to LC-MS/MS, GC-MS and Desorption Electrospray Ionization - Imaging Mass Spectrometry.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenfeng Zhao, MD

CONTACT

[email protected]

010-83198650

Xiaolei Liu, MD & PhD

CONTACT

[email protected]

010-83198650

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

The Changes of Genes, Proteins, and Metabolites in Patients with Drug-resistant Epilepsy

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 30, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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