NCT04954729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

July 6, 2021

Last Update Submit

July 6, 2021

Conditions

Keywords

Processing speedEpilepsyPositron emission tomographyFunctional magnetic resonance imaging

Outcome Measures

Primary Outcomes (3)

  • Processing speed index

    Processing speed index was measured according to Wechsler Intelligence Scale for Children

    Through study completion, about 2 years

  • Standardized uptake value ratio

    Standardized uptake value ratio was measured from 18F-FDG PET for brain glucose metabolism

    Through study completion, about 2 years

  • Functional connectivity

    Functional connectivity was measured from fMRI for brain regional interactions

    Through study completion, about 2 years

Study Arms (3)

Experimental Group

The experimental group underwent neuropsychological testing, 18F-FDG PET/CT, 3T resting state fMRI examinations.

MRI Control Group

The MRI control group underwent neuropsychological testing and 3T resting state fMRI examinations

PET Control Group

The PET control group underwent 18F-FDG PET/CT examination

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients with childhood epilepsy with centrotemporal spikes

You may qualify if:

  • (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

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

  • Li Y, Zhang T, Feng J, Qian S, Wu S, Zhou R, Wang J, Sa G, Wang X, Li L, Chen F, Yang H, Zhang H, Tian M. Processing speed dysfunction is associated with functional corticostriatal circuit alterations in childhood epilepsy with centrotemporal spikes: a PET and fMRI study. Eur J Nucl Med Mol Imaging. 2022 Jul;49(9):3186-3196. doi: 10.1007/s00259-022-05740-w. Epub 2022 Feb 24.

MeSH Terms

Conditions

Epilepsy, RolandicEpilepsy

Condition Hierarchy (Ancestors)

Epilepsies, PartialBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 8, 2021

Study Start

June 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 30, 2021

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations