EpilepsyNCT05443958
The Role of Intracranial Electroencephalography (IEEG) in the Localization of Epileptogenic Zones (EZ) and Its Relationship With Prognosis
An observational study of Epilepsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The mechanism of epilepsy pathogenesis is complex and not fully defined, and about 20-30% of patients with seizures that cannot be completely controlled by drugs become drug-resistant epilepsy. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Epilepsy
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We reviewed consecutive patients with drug-resistant focal epilepsy who underwent intracranial electroencephalography (IEEG) evaluation as well as resective surgery in our epilepsy centre. They were all followed-up for > 1 years after surgery. The patients had a comprehensive evaluation including detailed history, neuropsychological testing, neuroimaging study and video-EEG examination.
Who may be able to join
- Complete clinical history;
- IEEG monitoring at least one habitual seizure；
- Follow up for at least 1 year；
- Signed informed consent.
Who cannot join
- Habitual seizures were not found in iEEG monitoring;
- No operation was performed;
- Lost to follow-up for various reasons within 1 year after surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, 310009
+86 0571 87783759, keyanlunli_zheer@163.com
About this study
Official title: The Role of IEEG in the Localization of EZ and Its Relationship With Prognosis
The mechanism of epilepsy pathogenesis is complex and not fully defined, and about 20-30% of patients with seizures that cannot be completely controlled by drugs become drug-resistant epilepsy. For focal drug-resistant epilepsy, surgical removal of the epileptogenic zone can control seizures, but the overall seizure-free rate in the long term after surgery is 60-70%, and the results are still not satisfactory. Accurate assessment of the location and extent of the epileptogenic zone and its adequate excision are prerequisites for the success or failure of surgery. Intracranial EEG (iEEG) has been shown to be the most accurate method for determining the location and boundaries of the epileptogenic zone. It can selectively record the local cortical electrical activity through intracranial electrodes and achieve high temporal resolution for long-range recording, reliably reflecting the continuous dynamic changes of EEG during interictal and ictal periods. The in-depth analysis of iEEG can improve the efficacy of epilepsy surgery and provide important information to reveal the pathogenesis of epilepsy.
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| Seizure free group | Not described | |
| Not seizure free group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical data and IEEG characteristics in the seizure-free and not seizure-free groups
Compare two groups of patients with clinical data (sex, age at onset, age at surgery, epilepsy duration, seizure lateralization/localization, MRI findings, Pathology) and EEG characteristics (contact number, EEG onset pattern, IEEG power of each frequency band, functional connectivity of each frequency band).
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2025 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443958
- Sponsor's protocol ID
- 2020-910
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- 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 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of IEEG in the Localization of EZ and Its Relationship With Prognosis
- ClinicalTrials.gov ID
- NCT05443958
- Acronym / sponsor ID
- 2020-910
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Jul 2022 (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.
The mechanism of epilepsy pathogenesis is complex and not fully defined, and about 20-30% of patients with seizures that cannot be completely controlled by drugs become drug-resistant epilepsy. For focal drug-resistant epilepsy, surgical removal of the epileptogenic zone can control seizures, but the overall seizure-free rate in the long term after surgery is 60-70%, and the results are still not satisfactory. Accurate assessment of the location and extent of the epileptogenic zone and its adequate excision are prerequisites for the success or failure of surgery. Intracranial EEG (iEEG) has been shown to be the most accurate method for determining the location and boundaries of the epileptogenic zone. It can selectively record the local cortical electrical activity through intracranial electrodes and achieve high temporal resolution for long-range recording, reliably reflecting the continuous dynamic changes of EEG during interictal and ictal periods. The in-depth analysis of iEEG can improve the efficacy of epilepsy surgery and provide important information to reveal the pathogenesis of epilepsy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seizure free group | – | – |
| Not seizure free group | – | – |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We reviewed consecutive patients with drug-resistant focal epilepsy who underwent intracranial electroencephalography (IEEG) evaluation as well as resective surgery in our epilepsy centre. They were all followed-up for > 1 years after surgery. The patients had a comprehensive evaluation including detailed history, neuropsychological testing, neuroimaging study and video-EEG examination.
Key inclusion criteria (4 listed)
- Complete clinical history;
- IEEG monitoring at least one habitual seizure；
- Follow up for at least 1 year；
- Signed informed consent.
Key exclusion criteria (3 listed)
- Habitual seizures were not found in iEEG monitoring;
- No operation was performed;
- Lost to follow-up for various reasons within 1 year after surgery.
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 |
|---|---|---|
| Other | Not seizure free group, Seizure free group |
Primary outcome
Comparison of clinical data and IEEG characteristics in the seizure-free and not seizure-free groups
Time frame: 1-2 years
Compare two groups of patients with clinical data (sex, age at onset, age at surgery, epilepsy duration, seizure lateralization/localization, MRI findings, Pathology) and EEG characteristics (contact number, EEG onset pattern, IEEG power of each frequency band, functional connectivity of each frequency band).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- 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. This study is not recruiting at the moment.
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, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingli Hu, Master (18613040114, hulingli21@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of clinical data and IEEG characteristics in the seizure-free and not seizure-free groups (time frame: 1-2 years). 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 5 Jul 2022.