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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04954729
Other study ID # 2019-266
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date June 30, 2021

Study information

Verified date July 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date June 30, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Processing speed index Processing speed index was measured according to Wechsler Intelligence Scale for Children Through study completion, about 2 years
Primary Standardized uptake value ratio Standardized uptake value ratio was measured from 18F-FDG PET for brain glucose metabolism Through study completion, about 2 years
Primary Functional connectivity Functional connectivity was measured from fMRI for brain regional interactions Through study completion, about 2 years
See also
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Terminated NCT00471744 - HEAD-Study Optimizing the Treatment of Children With BECTS Phase 3
Completed NCT00216567 - Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy Phase 4