A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms (SPASMES-NIRS)
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|ClinicalTrials.gov Identifier: NCT02899832|
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : August 10, 2018
This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. This will be carried out by combining optical imaging using near infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous high-resolution (HR) recording.
This study is among those based on multimodal analyses of epilepsy, combining methods of analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).
Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal dysfunction from a functional point view. It is used in the routine follow-up of children with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non invasive, and inoffensive which could easily be used at the child's bedside or in a clinical setting and can provide metabolic information about cerebral function.
This study is multidisciplinary, which calls upon the skills of neurophysiologists, biophysicists, and clinicians
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms|
|Actual Study Start Date :||February 21, 2013|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
Near Infra Red Spectroscopy.
Near Infra Red Spectroscopy
- changes in HbO [ Time Frame: Day 0 ]hemodynamic changes in [HbO] before spasms, during spasms, and after spasms
- changes in Hbr [ Time Frame: Day 0 ]hemodynamic changes in [Hbr] before spasms, during spasms, and after spasms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899832
|Contact: Fabrice WALLOIS, MD, PhD||+33 3 22 08 77 email@example.com|
|Amiens, France, 80054|
|Contact: Fabrice WALLOIS, MD, PhD +33 3 22 08 77 77 firstname.lastname@example.org|
|Fondation Ophtalmologique Rothshild||Recruiting|
|Paris, France, 75019|
|Contact: Mathilde CHIPEAU, MD|
|Principal Investigator:||Fabrice WALLOIS, MD, PhD||CHU Amiens|