- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02814331
Electrohaemodynamic Activity in Epileptic Children : Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis (NIRS Epilepsie)
August 2, 2018 updated by: Centre Hospitalier Universitaire, Amiens
Electrohaemodynamic Activity in Epileptic Children: Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis
Evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis to spatial localization of epileptogenic foci
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is designed to evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of epileptogenic foci in order to perform multimodal mapping and localization of interictal spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG electrode implantation strategy prior to surgery in children with drug-refractory partial epilepsy.
Study Type
Observational
Enrollment (Actual)
23
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
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-
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
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children between the ages of 6 and 18 years with drug-refractory partial epilepsy, presenting interictal spikes on standard EEG recordings.
Description
Inclusion Criteria:
- Children between the ages of 6 and 18 years
- with drug-refractory partial epilepsy, presenting interictal spikes on standard EEG recordings.
Exclusion Criteria:
- Children with a serious congenital malformation.
- Refusal from one of the parents or the child.
- Children with generalized epilepsy or diffuse interictal spikes.
- Children with severely impaired general status and vital functions.
- Children with dermatosis of the face or scalp.
- Children under the age of 6 years or adults over the age of 18 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
symptomatic partial epilepsy
whose brain MRI is abnormal multimodal high-resolution EEG-NIRS
|
|
not symptomatic partial epilepsy
whose brain MRI is normal multimodal high-resolution EEG-NIRS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
multimodal high-resolution EEG-NIRS
Time Frame: Day 0
|
to evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of epileptogenic foci in order to perform multimodal mapping and localization of interictal spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG electrode implantation strategy prior to surgery in children with drug-refractory partial epilepsy.
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional MRI
Time Frame: Day 0
|
to analyse the temporal dynamics of haemodynamic changes surrounding epileptic spikes.
|
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 (Actual)
October 14, 2011
Primary Completion (Actual)
April 24, 2015
Study Completion (Actual)
April 24, 2015
Study Registration Dates
First Submitted
June 23, 2016
First Submitted That Met QC Criteria
June 23, 2016
First Posted (Estimate)
June 27, 2016
Study Record Updates
Last Update Posted (Actual)
August 3, 2018
Last Update Submitted That Met QC Criteria
August 2, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRCN11-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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