Connectivity Alterations After Levetiracetam Application

Epilepsy Clinical Trial

Official title:

Connectivity Alterations of Brain Network in LGG Patients After Levetiracetam Application at Short Term

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04425798
• Other study ID #: KY 2019-038-03
• Status: Not yet recruiting
• Start date: May 25, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2020
• Source: Beijing Neurosurgical Institute
• Contact: Tao Jiang, MD and PhD
• Phone: +86-010-67021832
• Email: taojiang1964[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Epilepsy
• Glioma

Locations

Country	Name	City	State
China	Beijing Neurosurgical Institute and Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 2 years