Electrohaemodynamic Activity in Epileptic Children : Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis
NIRS Epilepsie
1 other identifier
observational
23
1 country
1
Brief Summary
Evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis to spatial localization of epileptogenic foci
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2015
CompletedFirst Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedAugust 3, 2018
August 1, 2018
3.5 years
June 23, 2016
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
multimodal high-resolution EEG-NIRS
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 Outcomes (1)
Functional MRI
Day 0
Study Arms (2)
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
Interventions
Eligibility Criteria
Children between the ages of 6 and 18 years with drug-refractory partial epilepsy, presenting interictal spikes on standard EEG recordings.
You may qualify if:
- Children between the ages of 6 and 18 years
- with drug-refractory partial epilepsy, presenting interictal spikes on standard EEG recordings.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80054, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrice WALLOIS, Md, PhD
CHU Amiens
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2016
First Posted
June 27, 2016
Study Start
October 14, 2011
Primary Completion
April 24, 2015
Study Completion
April 24, 2015
Last Updated
August 3, 2018
Record last verified: 2018-08