Association of Processing Speed Dysfunction and Brain Functional Abnormality in ECTS

Epilepsy, Rolandic Clinical Trial

Official title:

Association of Processing Speed Dysfunction and Brain Functional Abnormality in Childhood Epilepsy With Centrotemporal Spikes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04954729
• Other study ID #: 2019-266
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Rolandic

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