- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04917939
Gene Expression Changes of Brain Tissue in Human Temporal Lobe Epilepsy With Hippocampal Sclerosis
April 22, 2026 updated by: Junming Zhu, Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Epilepsy patients with or without hippocampal sclerosis.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
epilepsy with HS
|
Samples in both groups will be sequenced by single-cell sequencing and spatial transcription sequencing.
|
|
epilepsy without HS
|
Samples in both groups will be sequenced by single-cell sequencing and spatial transcription sequencing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RNA sequencing data
Time Frame: up to 24 weeks
|
Single-cell sequencing and spatial transcription sequencing data of samples.
|
up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: 2nd Affiliated Hospital, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 19, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
June 7, 2021
First Submitted That Met QC Criteria
June 7, 2021
First Posted (Actual)
June 8, 2021
Study Record Updates
Last Update Posted (Actual)
April 27, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Congenital Abnormalities
- Malformations of Cortical Development, Group I
- Malformations of Cortical Development
- Nervous System Malformations
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Hippocampal Sclerosis
- Epilepsy
- Investigative Techniques
- Genetic Techniques
- Sequence Analysis
- Sequence Analysis, RNA
Other Study ID Numbers
- 2021-0291
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.