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

NCT ID: NCT06665880

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2026-12-31

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.

Conditions

Drug Resistant Epilepsy; Traumatic Brain Injury Without Open Intracranial Wound

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

DRE patients

Patients with drug-resistant epilepsy.

Routine clinical treatment

Intervention Type: OTHER

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

Traumatic Brain Injury

Individuals with traumatic brain injury.

Routine clinical treatment

Intervention Type: OTHER

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

Interventions

Routine clinical treatment

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guoguang Zhao, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Hongxing Wang, MD & PhD

Role: STUDY_DIRECTOR

Xuanwu Hospital, Beijing

Yongzhi Shan, MD & PhD

Role: STUDY_DIRECTOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Countries

China

Central Contacts

Wenfeng Zhao, MD

Role: CONTACT

fengfeng_zw@ccmu.edu.cn

010-83198650

Xiaolei Liu, MD & PhD

Role: CONTACT

ring@vip.163.com

010-83198650

Facility Contacts

Hongxing Wang, MD & PhD

Role: primary

wanghongxing@xwh.ccmu.edu.cn

010-83198650

Other Identifiers

Brain Tissues

Identifier Type: -

Identifier Source: org_study_id