Connectivity Alterations After Levetiracetam Application

June 7, 2020 updated by: Beijing Neurosurgical Institute

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lianwang Li, MD
  • Phone Number: +86 18810647541
  • Email: ttyyllw@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Beijing Neurosurgical Institute and Beijing Tiantan Hospital

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with LGG presented GRE, take levetiracetam less than 1 month; or do not take any medicine and receive any treatment.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Contraindications for MRI;
  • Head motion greater than 3 mm in translation or 3° in rotation;

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

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Neurosurgical Institute

Collaborators

Beijing Tiantan Hospital

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 (Anticipated)

May 25, 2022

Primary Completion (Anticipated)

May 31, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 7, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY 2019-038-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share individual participant data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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