Drug Resistant EpilepsyNCT06665880
Genes, Proteins, and Metabolites in Drug-resistant Epilepsy (DRE) Patients
An observational study of Drug Resistant Epilepsy and Traumatic Brain Injury Without Open Intracranial Wound, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Drug Resistant Epilepsy, Traumatic Brain Injury Without Open Intracranial Wound
- What is being tested?
- Routine clinical treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with drug-resistant epilepsy.
Who may be able to join
- 14-60 years old, male or female, Han Chinese;
- Drug-resistant epilepsy;
- Required surgical implantation of SEEG electrodes.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Hongxing Wang, MD & PhD, 010-83198650, wanghongxing@xwh.ccmu.edu.cn
About this study
Official title: The Changes of Genes, Proteins, and Metabolites in Patients with Drug-resistant Epilepsy
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.
Read the 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.
- Being tested
- Routine clinical treatment
- Keywords
- Genomics, Proteomics, Metabolomics, Drug Resistant Epilepsy, Traumatic Brain Injury
- Medical subject headings
- Drug Resistant Epilepsy, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine clinical treatmentOther
Routine clinical treatment is based on the latest international guidelines for DRE.
| Study group | Role | What they receive |
|---|---|---|
| DRE patients | Patients with drug-resistant epilepsy. Receives: Other: Routine clinical treatment | |
| Traumatic Brain Injury | Individuals with traumatic brain injury. Receives: Other: Routine clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of one year
Secondary outcomes (2)
Differentially expressed proteins
Discovering differentially expressed proteins (DEPs) and their roles in DRE patients, we will conduct 4D-DIA quantitative proteomics analysis.
Measured: through study completion, an average of one year
The concentration of metabolites
Metabolites of cancerous and paracancerous tissues in patients will be subjected to LC-MS/MS, GC-MS and Desorption Electrospray Ionization - Imaging Mass Spectrometry.
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Dec 2025 (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 Drug Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoguang Zhao, MD & PhD, Principal investigator, Xuanwu Hospital, BeijingHongxing Wang, MD & PhD, Study director, Xuanwu Hospital, BeijingYongzhi Shan, MD & PhD, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665880
- Sponsor's protocol ID
- Brain Tissues
- Status last verified
- Oct 2024
- First submitted
- 5 Aug 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes of Genes, Proteins, and Metabolites in Patients with Drug-resistant Epilepsy
- ClinicalTrials.gov ID
- NCT06665880
- Acronym / sponsor ID
- Brain Tissues
- Keywords
- Genomics, Proteomics, Metabolomics, Drug Resistant Epilepsy, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Oct 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DRE patients | – | Other: Routine clinical treatmentPatients with drug-resistant epilepsy. |
| Traumatic Brain Injury | – | Other: Routine clinical treatmentIndividuals with traumatic brain injury. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with drug-resistant epilepsy.
Key inclusion criteria (3 listed)
- 14-60 years old, male or female, Han Chinese;
- Drug-resistant epilepsy;
- Required surgical implantation of SEEG electrodes.
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| Routine clinical treatmentRoutine clinical treatment is based on the latest international guidelines for DRE. | Other | DRE patients, Traumatic Brain Injury |
Primary outcome
Single cell RNA sequencing
Time frame: through study completion, an average of one year
Cancerous and paracancerous tissues of patients will be subjected to10x Genomics single-cell RNA sequencing, Bulk RNA-seq and spatial transcriptome.
2 secondary outcomes
Differentially expressed proteins
Time frame: through study completion, an average of one year
The concentration of metabolites
Time frame: through study completion, an average of one year
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 30 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Guoguang Zhao, MD & PhD principal investigator
Xuanwu Hospital, Beijing
Hongxing Wang, MD & PhD study director
Xuanwu Hospital, Beijing
Yongzhi Shan, MD & PhD study director
Xuanwu Hospital, Beijing
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 Drug Resistant Epilepsy and Traumatic Brain Injury Without Open Intracranial Wound, run by Xuanwu Hospital, Beijing 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 30 Oct 2024. 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?
Contact Wenfeng Zhao, MD (010-83198650, fengfeng_zw@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single cell RNA sequencing (time frame: through study completion, an average of one year). 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 30 Oct 2024.