Association of Processing Speed Dysfunction and Brain Functional Abnormality in ECTS

NCT ID: NCT04954729

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy, Rolandic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

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

No interventions assigned to this group

MRI Control Group

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

No interventions assigned to this group

PET Control Group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35199226 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-266

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.