The Metabolic Characteristics in Sublobar Areas of PRE Based on FDG-PET Study

The Metabolic Characteristics in Sublobar Areas of Pharmacoresistant Epilepsy Based on FDG-PET Study

Epilepsy is a chronic brain disease that is caused by various factors and characterized by recurrent, episodic and temporary central nervous system dysfunction. In the past few decades, despite the continuous development of antiepileptic drugs, there are still 20%-30% patients with epilepsy progressing to pharmacoresistant epilepsy (PRE), which leads to a significant increase in the morbidity and mortality of epilepsy. For those fraction of PRE, surgical treatment may be the only possible way to cure epilepsy. Accurate presurgical evaluation play an important role in making surgery decision and defining surgical extent and achieve better surgical outcome. Imaging, especially interictal fluorine-18-fluorodeoxyglucose-positron emission tomography (FDG-PET) is widely used in preoperative evaluation, which is of great significance in the detection of epileptogenic foci. Previous studies on FDG-PET have found that FDG-PET has a wide range of hypometabolism inpatients of PRE varying from different epileptic origins. Therefore, exploring the characteristics of glucose metabolism originating in different brain areas of resistant epilepsy can help to better interpret the results of FDG-PET and guide the preoperative localization of such patiens and better understand the potential mechanism of seizure propagation in PRE.

Study Overview

• Status: Recruiting
• Conditions: Interictal FDG-PET Hypometabolism Patterns
• Intervention / Treatment: Other: non interventional

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Yao Ding, doctor; Phone Number: 13588015954; Email: zjdingyao@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Yao Ding, doctor; Phone Number: 13588015954; Email: zjdingyao@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We prospectively recruited 100 consecutive patients with pharmacoresistant epilepsy at our epilepsy center since Nov 2020. All the patients should have agreed to sign an informed consent.

Description

Inclusion Criteria: (a) Pharmacoresistant Epilepsy may be defined by International League Against Epilepsy (ILAE）as failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom (judged by two epileptologists); (b) conventional MRI negative or nonspecific abnormalities; and (c) detailed information of long-term video-EEG, FDG-PET, high resolution MRI (HR-MRI) and neuropsychological assessment were acquired, (d) focal epilepsy defined by combining clinical, electrophysical and neuroimaging.

Exclusion Criteria: (a) generalized or multifocal epilepsy or the patient's electroclinical features were inconsistent with pharmacoresistant epilepsy; (b) idiopathic focal epilepsy; and (c) unsatisfactory imaging quality.

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypometabolic patterns for each patient group comparing with control group	Due to the different epileptogenic zones in each group, the hypometabolic patterns should be different	1-3months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (ACTUAL): November 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020-743

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No