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

Not yet recruiting

• Conditions: Drug Resistant Epilepsy; Traumatic Brain Injury Without Open Intracranial Wound

• Registration Number: NCT06665880
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-08-05
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Study Start: 2024-11-15
• Primary Completion: 2025-12-15
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. 14-60 years old, male or female, Han Chinese;
2. Drug-resistant epilepsy;
3. Required surgical implantation of SEEG electrodes.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Single cell RNA sequencing	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 Outcome Measures

Name	Time	Method
Differentially expressed proteins	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.
The concentration of metabolites	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.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China