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

NCT06665880 | Not Yet Recruiting DMC

• 1 other identifier: Brain Tissues
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Resistant Epilepsy; Traumatic Brain Injury Without Open Intracranial Wound

Keywords

Genomics; Proteomics; Metabolomics; Drug Resistant Epilepsy; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Single cell RNA sequencing

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

  through study completion, an average of one year

Secondary Outcomes (2)

• Differentially expressed proteins

  through study completion, an average of one year

• The concentration of metabolites

  through study completion, an average of one year

Study Arms (2)

DRE patients

Patients with drug-resistant epilepsy.

Other: Routine clinical treatment

Traumatic Brain Injury

Individuals with traumatic brain injury.

Other: Routine clinical treatment

Interventions

Routine clinical treatment OTHER

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

DRE patients; Traumatic Brain Injury

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with drug-resistant epilepsy.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Epileptogenic and para-epileptogenic tissues from DRE patients and normal tissues from individuals with traumatic brain injury.

MeSH Terms

Conditions

Drug Resistant Epilepsy; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Guoguang Zhao, MD & PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Hongxing Wang, MD & PhD

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

• Yongzhi Shan, MD & PhD

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Wenfeng Zhao, MD

CONTACT

010-83198650; fengfeng_zw@ccmu.edu.cn

Xiaolei Liu, MD & PhD

CONTACT

010-83198650; ring@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: October 30, 2024
• Study Start: November 15, 2024
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)