Clinical trial NCT04425798: Connectivity Alterations After Levetiracetam Application
Official title: Connectivity Alterations of Brain Network in LGG Patients After Levetiracetam Application at Short Term
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Epilepsy
Keywords: glioma
glioma-related epilepsy
levetiracetam
connectivity alteration
Lead sponsor: Beijing Neurosurgical Institute
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
First posted: 2020-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: The connectivity alterations of brain networks in patients with and without levetiracetam application
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Neurosurgical Institute and Beijing Tiantan Hospital
state: Beijing
Study officials:
References: