Connectivity Alterations After Levetiracetam Application

NCT ID: NCT04425798

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-25

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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Glioma Epilepsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Patients without LEV application

LGG patients with GRE do not take any medicine or receive any treatment preoperatively.

No interventions assigned to this group

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Neurosurgical Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Tao Jiang, MD and PhD

Role: CONTACT

+86-010-67021832

Lianwang Li, MD

Role: CONTACT

+86 18810647541

Facility Contacts

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Tao Jiang, MD and PhD

Role: primary

+86-010-67021832

Other Identifiers

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KY 2019-038-03

Identifier Type: -

Identifier Source: org_study_id

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