Clinical trial NCT06665880: Genes, Proteins, and Metabolites in Drug-resistant Epilepsy (DRE) Patients
Official title: The Changes of Genes, Proteins, and Metabolites in Patients with Drug-resistant Epilepsy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Drug Resistant Epilepsy
Traumatic Brain Injury Without Open Intracranial Wound
Keywords: Genomics
Proteomics
Metabolomics
Drug Resistant Epilepsy
Traumatic Brain Injury
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with drug-resistant epilepsy.

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.

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.

Primary outcomes:
measure: Single cell RNA sequencing
timeFrame: through study completion, an average of one year
Secondary outcomes:
measure: Differentially expressed proteins
timeFrame: through study completion, an average of one year
measure: The concentration of metabolites
timeFrame: through study completion, an average of one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Guoguang Zhao, MD & PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuanwu Hospital, Beijing
name: Hongxing Wang, MD & PhD
role: STUDY_DIRECTOR
affiliation: Xuanwu Hospital, Beijing
name: Yongzhi Shan, MD & PhD
role: STUDY_DIRECTOR
References: