Concomitant High-resolution Recording of Haemodynamic and Electrical Activities of Children With Typical or Atypical Absence Seizures (Absence)

August 20, 2018 updated by: Centre Hospitalier Universitaire, Amiens

Concomitant High-resolution Recording of Haemodynamic and Electrical Activities of Children With Typical or Atypical Absence Seizures: Near-infrared Spectroscopy (NIRS) Coupled to Electroencephalography (EEG)

This study, conducted in children with typical or atypical "absence" epilepsy, will consist of noninvasive recording of the metabolic activity of the brain concomitantly with electroencephalographic recording during seizures without the need for any additional examination. This examination will be performed by combining near-infrared spectroscopy (NIRS) optical imaging and Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording.

Surface electroencephalography (EEG) is a valuable tool to assess neuronal dysfunction from a functional point of view and is used in the routine follow-up of epileptic children. Optical imaging is a recent and promising medical imaging technique, which uses near-infrared light. This rapid, noninvasive and harmless quantitative technique can be easily used at the child's bedside or in the ward and provides metabolic information on brain functioning.

Study Overview

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children with absence epilepsy presenting either typical or atypical seizures

Description

Inclusion Criteria:

  • Children aged 3 to 14 years
  • Featuring absence epilepsy with typical or atypical seizures characterized by the presence of spontaneous spike-wave flashes with standard EEG

Exclusion Criteria:

  • All children with severe congenital malformation
  • Any refusal of a parent or child
  • Any child with a serious deterioration in the general condition and vital functions
  • Any child with dermatitis of the face or scalp
  • Children under 3 years old or over 14 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
epilepsy
children with absence epilepsy presenting either typical or atypical seizures
Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
haemodynamic changes
Time Frame: Day 0
haemodynamic changes by optical imaging, during the 4 interictal, preictal, ictal and postictal phases of absence seizures as defined by EEG analysis
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

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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