EpilepsyAEHCEENCT02826915
Electro- Hemodynamic Activity in Children: Combined Analysis by Video -EEG Spectroscopy and Near-infrared (NIRS )
An observational study of Epilepsy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Epilepsy in children is a major public health issue. It is the first neurological disease of the child. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Near Infra Red Spectroscopy (NIRS) and Electroencephalogram (EEG)
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2010to 21 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: The inclusion of patients in the study will be conducted by doctors of the unit of pediatric neurology, intensive care or critical care of the Amiens hospital. The purchases will be made as part of the normal management of all children who have a électroecéphalographique followed.
Who may be able to join
- Any child 0-16 years with partial epilepsy and / or interictal spikes located on the standard EEG recordings.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Epilepsy in children is a major public health issue. It is the first neurological disease of the child.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Near Infra Red Spectroscopy (NIRS), Electroencephalogram (EEG)
- Keywords
- newborn, infant, child, EEG, NIRS
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infra Red Spectroscopy (NIRS)Device
Electroencephalogram (EEG)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
HbO
concentration modification (Hz) of oxygenated hemoglobin (HbO) during the interictal spikes and seizures in infants and children.
Measured: Hour 1
HHb
concentration modification (Hz) of deoxygenated hemoglobin (HHb) during the interictal spikes and seizures in infants and children.
Measured: Hour 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start5 Feb 2010
- Primary completion21 Mar 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice WALLOIS, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826915
- Sponsor's protocol ID
- PI09-DR-WALLOIS
- Acronym
- AEHCEE
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro- Hemodynamic Activity in Children: Combined Analysis by Video -EEG Spectroscopy and Near-infrared (NIRS )
- ClinicalTrials.gov ID
- NCT02826915
- Acronym / sponsor ID
- AEHCEE / PI09-DR-WALLOIS
- Conditions
- Epilepsy
- Keywords
- newborn, infant, child, EEG, NIRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 5 Feb 2010 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epilepsy in children is a major public health issue. It is the first neurological disease of the child.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The inclusion of patients in the study will be conducted by doctors of the unit of pediatric neurology, intensive care or critical care of the Amiens hospital. The purchases will be made as part of the normal management of all children who have a électroecéphalographique followed.
Key inclusion criteria (1 listed)
- Any child 0-16 years with partial epilepsy and / or interictal spikes located on the standard EEG recordings.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infra Red Spectroscopy (NIRS) | Device | – |
| Electroencephalogram (EEG) | Device | – |
Primary outcome
HbO
Time frame: Hour 1
concentration modification (Hz) of oxygenated hemoglobin (HbO) during the interictal spikes and seizures in infants and children.
HHb
Time frame: Hour 1
concentration modification (Hz) of deoxygenated hemoglobin (HHb) during the interictal spikes and seizures in infants and children.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice WALLOIS, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbO (time frame: Hour 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.