- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826915
Electro- Hemodynamic Activity in Children: Combined Analysis by Video -EEG Spectroscopy and Near-infrared (NIRS ) (AEHCEE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Epilepsy in children is a major public health issue. It is the first neurological disease of the child. The specific incidence of epilepsy rates were highest during the first year of life, between 75,105 and 250,105 hab.an hab. year and remain high in the age group between 0 and 10 years. Epilepsies predictions are varied. They can be spontaneously benign, drug-, chemically dependent or drug-resistant. These, refractory epilepsies, represent 20% of epilepsy as a child and adolescent than adult is about 1200 children and 1200 adults Picardy. The validation of non-invasive investigative tools is becoming a necessity in the management of drug-resistant epilepsies especially when a surgical decision is envisaged. The aftermath (motor, cognitive, sensory) appear to rule early; but they are sometimes limited to learning deficits detected later in the school curriculum. The investigators know that defects in neuronal electrical activity (eg critical discharges) induce a metabolic response and conversely metabolic disturbances can cause abnormal electrical activity. It is therefore important to have tools to better characterize the interactions between these two mechanisms to better understand brain function in the brain during development and during pathological situations. The investigators lack quantitative criteria regarding the impact of crises on the metabolic activity and thus predictive criteria consequences of crises on brain function. The deleterious hazard must be considered at all ages in both structures to causing seizures than in those where the crisis spread. The functional characterization, electrical, metabolic and anatomic pathology of these networks is necessary and contributes to a better understanding of physiological and pathological brain function, and helps to define the most appropriate treatment strategy.
About childhood epilepsy, analysis of the EEG allows in 75% of cases to find predictive patterns characteristic of becoming. However in 25% of cases, we lack predictive objective criteria. This highlights the importance of developing analysis tools for more accurate and efficient brain function and to improve the management and evaluation of the prognosis of these children.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Fabrice WALLOIS, MD, PhD
- Phone Number: +33 3 22 08 77 77
- Email: wallois.fabrice@chu-amiens.fr
Study Locations
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-
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Amiens, France, 80054
- Recruiting
- CHU Amiens
-
Contact:
- Fabrice WALLOIS, MD, PhD
- Phone Number: +33 3 22 08 77 77
- Email: wallois.fabrice@chu-amiens.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any child 0-16 years with partial epilepsy and / or interictal spikes located on the standard EEG recordings.
Exclusion Criteria:
- All children with severe congenital malformation
- Any refusal of a parent
- Any child with generalized epilepsy or diffuse interictal spikes
- Any child with a serious deterioration in the general condition and vital functions
- Any child with dermatitis of the face or scalp
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbO
Time Frame: Hour 1
|
concentration modification (Hz) of oxygenated hemoglobin (HbO) during the interictal spikes and seizures in infants and children.
|
Hour 1
|
HHb
Time Frame: Hour 1
|
concentration modification (Hz) of deoxygenated hemoglobin (HHb) during the interictal spikes and seizures in infants and children.
|
Hour 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
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
- PI09-DR-WALLOIS
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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