GliomaNCT04425798
Connectivity Alterations After Levetiracetam Application
An observational study of Glioma and Epilepsy, run by Beijing Neurosurgical Institute at 1 site in China.
Trial summary
This study aimed to analyze the connectivity alterations in brain networks of LGG patients with epilepsy who take levetiracetam at short-term preoperatively. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2022to 30 Sep 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with LGG presented GRE, take levetiracetam less than 1 month; or do not take any medicine and receive any treatment.
Who may be able to join
- Age ≥ 18 years;
- Histopathological diagnosis with LGG according to the 2016 World Health Organization (WHO) criteria;
- Participants received more than 6 years of school education;
- Presence of GRE, take levetiracetam less than 1 month; or do not take any medicine and receive any treatment;
- No history of biopsy, radiotherapy, or chemotherapy.
Who cannot join
- Contraindications for MRI;
- Head motion greater than 3 mm in translation or 3° in rotation;
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Tao Jiang, MD and PhD, +86-010-67021832, taojiang1964@163.com
About this study
Official title: Connectivity Alterations of Brain Network in LGG Patients After Levetiracetam Application at Short Term
This study aimed to analyze the connectivity alterations in brain networks of LGG patients with epilepsy who take levetiracetam at short-term preoperatively.
Read the detailed description
Glioma-related epilepsy (GRE) is a very common symptom in patients with diffuse gliomas. Approximately 60% of patients with low-grade gliomas (LGGs) and 40-64% of patients with high-grade gliomas presented with GRE at the onset. Although beneficial for the control of GRE, the overall therapeutic effect was unsatisfied and over 20% of patients still suffered from seizures.
GRE was found to be associated with brain network and functional connectivity. And it has been reported that temporal lobe seizures could induce functional connectivity and decreased network efficiency of brain networks. However, the alterations in functional networks induced by GRE were still unclear. And LGG patients with GRE usually take levetiracetam (LEV) preoperatively, which could effectively reduce abnormal spike activity and further cause connectivity alterations. This makes it more complex to reveal the connectivity alterations of brain networks in LGG patients with GRE.
This study aimed to collect the resting-state functional MRIs of 30 LGG patients who presented with GRE at the onset. Through further applied graph theory analysis, investigators tend to reveal the connectivity alterations of brain networks caused by levetiracetam. The findings of this study will provide a theoretical basis for further study of connectivity alterations of brain networks in patients with GRE.
- Keywords
- glioma, glioma-related epilepsy, levetiracetam, connectivity alteration
- Medical subject headings
- Glioma, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with LEV application | LGG patients with GRE take levetiracetam less than 1 month preoperatively. These patients take levetiracetam tablets twice a day, and one tablet at a time. Each levetiracetam tablet contains 500mg levetiracetam. | |
| Patients without LEV application | LGG patients with GRE do not take any medicine or receive any treatment preoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The connectivity alterations of brain networks in patients with and without levetiracetam application
Graph theory analysis is used to delineate topological networks with resting-state functional MRIs and investigated the characteristics of functional networks. Global and nodal topological properties of brain networks are calculated in the two groups of patients. The difference of topological properties of brain networks between patients with and without levetiracetam application are analyzed using t-test or chi-square test according to the type of data.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start25 May 2022 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425798
- Sponsor's protocol ID
- KY 2019-038-03
- Status last verified
- May 2020
- First submitted
- 2 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connectivity Alterations of Brain Network in LGG Patients After Levetiracetam Application at Short Term
- ClinicalTrials.gov ID
- NCT04425798
- Acronym / sponsor ID
- KY 2019-038-03
- Keywords
- glioma, glioma-related epilepsy, levetiracetam, connectivity alteration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 25 May 2022 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 11 Jun 2020 (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.
This study aimed to analyze the connectivity alterations in brain networks of LGG patients with epilepsy who take levetiracetam at short-term preoperatively.
Detailed description
Glioma-related epilepsy (GRE) is a very common symptom in patients with diffuse gliomas. Approximately 60% of patients with low-grade gliomas (LGGs) and 40-64% of patients with high-grade gliomas presented with GRE at the onset. Although beneficial for the control of GRE, the overall therapeutic effect was unsatisfied and over 20% of patients still suffered from seizures.
GRE was found to be associated with brain network and functional connectivity. And it has been reported that temporal lobe seizures could induce functional connectivity and decreased network efficiency of brain networks. However, the alterations in functional networks induced by GRE were still unclear. And LGG patients with GRE usually take levetiracetam (LEV) preoperatively, which could effectively reduce abnormal spike activity and further cause connectivity alterations. This makes it more complex to reveal the connectivity alterations of brain networks in LGG patients with GRE.
This study aimed to collect the resting-state functional MRIs of 30 LGG patients who presented with GRE at the onset. Through further applied graph theory analysis, investigators tend to reveal the connectivity alterations of brain networks caused by levetiracetam. The findings of this study will provide a theoretical basis for further study of connectivity alterations of brain networks in patients with GRE.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with LEV application | – | –LGG patients with GRE take levetiracetam less than 1 month preoperatively. These patients take levetiracetam tablets twice a day, and one tablet at a time. Each levetiracetam tablet contains 500mg levetiracetam. |
| Patients without LEV application | – | –LGG patients with GRE do not take any medicine or receive any treatment preoperatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with LGG presented GRE, take levetiracetam less than 1 month; or do not take any medicine and receive any treatment.
Key inclusion criteria (5 listed)
- Age ≥ 18 years;
- Histopathological diagnosis with LGG according to the 2016 World Health Organization (WHO) criteria;
- Participants received more than 6 years of school education;
- Presence of GRE, take levetiracetam less than 1 month; or do not take any medicine and receive any treatment;
- No history of biopsy, radiotherapy, or chemotherapy.
Key exclusion criteria (2 listed)
- Contraindications for MRI;
- Head motion greater than 3 mm in translation or 3° in rotation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The connectivity alterations of brain networks in patients with and without levetiracetam application
Time frame: through study completion, an average of 2 years
Graph theory analysis is used to delineate topological networks with resting-state functional MRIs and investigated the characteristics of functional networks. Global and nodal topological properties of brain networks are calculated in the two groups of patients. The difference of topological properties of brain networks between patients with and without levetiracetam application are analyzed using t-test or chi-square test according to the type of data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data with other researchers
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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 Glioma and Epilepsy, run by Beijing Neurosurgical Institute 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 5 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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 Tao Jiang, MD and PhD (+86-010-67021832, taojiang1964@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The connectivity alterations of brain networks in patients with and without levetiracetam application (time frame: through study completion, an average of 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 11 Jun 2020.