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Completed

NCT Number: NCT02814331

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

multimodal high-resolution EEG-NIRS

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. Functional MRI

    Time frame: Day 0

    to analyse the temporal dynamics of haemodynamic changes surrounding epileptic spikes.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Electrohaemodynamic Activity in Epileptic Children: Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis

Acronym: NIRS Epilepsie

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 27, 2016
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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