- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04954729
Association of Processing Speed Dysfunction and Brain Functional Abnormality in ECTS
Association of Processing Speed Dysfunction and Brain Functional Abnormality in Childhood Epilepsy With Centrotemporal Spikes
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Experimental Group
The experimental group underwent neuropsychological testing, 18F-FDG PET/CT, 3T resting state fMRI examinations.
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MRI Control Group
The MRI control group underwent neuropsychological testing and 3T resting state fMRI examinations
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PET Control Group
The PET control group underwent 18F-FDG PET/CT examination
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Processing speed index
Time Frame: Through study completion, about 2 years
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Processing speed index was measured according to Wechsler Intelligence Scale for Children
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Through study completion, about 2 years
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Standardized uptake value ratio
Time Frame: Through study completion, about 2 years
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Standardized uptake value ratio was measured from 18F-FDG PET for brain glucose metabolism
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Through study completion, about 2 years
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Functional connectivity
Time Frame: Through study completion, about 2 years
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Functional connectivity was measured from fMRI for brain regional interactions
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Through study completion, about 2 years
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-266
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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