- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02819427
Concomitant High-resolution Recording of Haemodynamic and Electrical Activities of Children With Typical or Atypical Absence Seizures (Absence)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Amiens, France, 80054
- CHU Amiens
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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:
- 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
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
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Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording.
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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
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Day 0
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2012_843_0025
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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