EpilepsyNCT04917939
Gene Expression Changes of Brain Tissue in Human Temporal Lobe Epilepsy With Hippocampal Sclerosis
An observational study of Epilepsy and Hippocampal Sclerosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy, Hippocampal Sclerosis
- What is being tested?
- RNA sequencing
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Epilepsy patients with or without hippocampal sclerosis.
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
About this study
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.
- Conditions
- Epilepsy, Hippocampal Sclerosis
- Being tested
- RNA sequencing
- Keywords
- Epilepsy, Hippocampal Sclerosis
- Medical subject headings
- Epilepsy, Hippocampal Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA sequencingOther
Samples in both groups will be sequenced by single-cell sequencing and spatial transcription sequencing.
| Study group | Role | What they receive |
|---|---|---|
| epilepsy with HS | Not described Receives: Other: RNA sequencing | |
| epilepsy without HS | Not described Receives: Other: RNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA sequencing data
Single-cell sequencing and spatial transcription sequencing data of samples.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start19 Apr 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junming Zhu, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- 2nd Affiliated Hospital, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917939
- Sponsor's protocol ID
- 2021-0291
- Status last verified
- Mar 2026
- First submitted
- 7 Jun 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Changes of Brain Tissue in Human Temporal Lobe Epilepsy With Hippocampal Sclerosis
- ClinicalTrials.gov ID
- NCT04917939
- Acronym / sponsor ID
- 2021-0291
- Conditions
- Epilepsy, Hippocampal Sclerosis
- Keywords
- Epilepsy, Hippocampal Sclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epilepsy with HS | – | Other: RNA sequencing |
| epilepsy without HS | – | Other: RNA sequencing |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Epilepsy patients with or without hippocampal sclerosis.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNA sequencingSamples in both groups will be sequenced by single-cell sequencing and spatial transcription sequencing. | Other | epilepsy with HS, epilepsy without HS |
Primary outcome
RNA sequencing data
Time frame: up to 24 weeks
Single-cell sequencing and spatial transcription sequencing data of samples.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2nd Affiliated Hospital study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Hippocampal Sclerosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RNA sequencing data (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.