Association of Processing Speed Dysfunction and Brain Functional Abnormality in ECTS

Completed

• Conditions: Epilepsy, Rolandic

• Registration Number: NCT04954729
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Epilepsy with centrotemporal spikes (ECTS) is the most common epilepsy syndrome in children. Language impairment has been widely investigated in patients with ECTS, but little is known about the cognitive dysfunction of processing speed and its neuroimaging mechanism.

Detailed Description

OBJECTIVE To investigate the processing speed dysfunction in patients with ECTS, and the associated brain functional abnormality using functional magnetic resonance imaging (fMRI) and 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET).

DESIGN, SETTING, AND PARTICIPANTS This study prospectively enrolled ECTS patients (n = 28) from June 2019 and June 2021. Twenty age- and gender- matched healthy children and another twenty children with extracranial tumors were enrolled as controls. Patients with ECTS and healthy controls underwent neuropsychological testing and fMRI examination. In addition, ECTS patients and children with extracranial tumors underwent 18F-FDG PET examination.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-30
• Status Verified: 2021-07
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-06
• Last Update Submitted: 2021-07-06
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• (a) age between 6 and 18 years; (b) 18F-FDG PET examination more than 48 h since the last seizure, (c) no structural abnormalities associated with epilepsy detected on routine MRI

Exclusion Criteria

• (a) any history of other neurological or psychiatric disorders; (b) pre-scan plasma glucose level > 120 mg/dl before 18F-FDG PET/CT examination;(c) any contraindications for MRI examination ; (d) head movement (translation > 3 mm or rotation > 3 degree ) during MRI examination

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Processing speed index	Through study completion, about 2 years	Processing speed index was measured according to Wechsler Intelligence Scale for Children
Standardized uptake value ratio	Through study completion, about 2 years	Standardized uptake value ratio was measured from 18F-FDG PET for brain glucose metabolism
Functional connectivity	Through study completion, about 2 years	Functional connectivity was measured from fMRI for brain regional interactions

Trial Locations

Locations (1)

Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China