NCT04917939

Brief Summary

Epilepsy is a common neurological disease, manifested in the sudden abnormal discharge of neurons leading to short-term brain dysfunction, has become the neurology after headache the second most common disease. In China, the prevalence of epilepsy is about 4.7-8.5 per 1,000, and more than 400,000 new cases of epilepsy are developed each year. Of these, 30% of patients were treated with ineffective medication, developing into a drug-incurable epilepsy that required surgery and other treatments. The most common type of epilepsy is temporal lobe epilepsy, while the common complication in temporal lobe epilepsy is hippocampal sclerosis, which often requires surgical removal. The incidence of inner temporal lobe epilepsy associated with hippocampal sclerosis is increasing, but its exact cause and specific pathogenesis are still unclear, so clarifying its pathogenesis will contribute to the understanding of temporal lobe epilepsy and the improvement of surgical procedures. This study is intended to get single-cell transcriptome as well as spatial transcriptome data of temporal lobe and hippocampus samples. By studying gene expression change associated with epilepsy and hippocampus sclerosis, we intended to find possible prognostic-related molecules and to deepen understanding of pathological changes in epilepsy at the molecular level.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Apr 2021Dec 2026

Study Start

First participant enrolled

April 19, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 27, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

June 7, 2021

Last Update Submit

April 22, 2026

Conditions

Keywords

EpilepsyHippocampal Sclerosis

Outcome Measures

Primary Outcomes (1)

  • RNA sequencing data

    Single-cell sequencing and spatial transcription sequencing data of samples.

    up to 24 weeks

Study Arms (2)

epilepsy with HS

Other: RNA sequencing

epilepsy without HS

Other: RNA sequencing

Interventions

Samples in both groups will be sequenced by single-cell sequencing and spatial transcription sequencing.

epilepsy with HSepilepsy without HS

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Epilepsy patients with or without hippocampal sclerosis.

You may qualify if:

  • Patients confirmed in our hospital as having temporal lobe epilepsy and intending surgery to remove temporal lobe and hippocampal tissue;
  • Volunteer to participate in this clinical trial, comply with the requirements of this clinical trial and sign an informed consent form.

You may not qualify if:

  • Chronic diseases of the central nervous system other than temporal lobe epilepsy;
  • Other patients that are not suitable for this clinical trial determined by the researchers;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

EpilepsyHippocampal Sclerosis

Interventions

Sequence Analysis, RNA

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesMalformations of Cortical Development, Group IMalformations of Cortical DevelopmentNervous System MalformationsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative Techniques

Study Officials

  • 2nd Affiliated Hospital

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 8, 2021

Study Start

April 19, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 27, 2026

Record last verified: 2026-03

Locations