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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

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
Epilepsy Device: NIRS

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NIRS
Near Infra Red Spectroscopy.
Device: NIRS
Near Infra Red Spectroscopy




Primary Outcome Measures :
  1. changes in HbO [ Time Frame: Day 0 ]
    hemodynamic changes in [HbO] before spasms, during spasms, and after spasms

  2. changes in Hbr [ Time Frame: Day 0 ]
    hemodynamic changes in [Hbr] before spasms, during spasms, and after spasms



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children between 3 and 6 years old presenting infantile spasms
Criteria

Inclusion Criteria:

  • Children between 3 and 6 years old presenting infantile spasms according to the Classification of the International League Against Epilepsy

Exclusion Criteria:

  • Children younger than 3 months and older than 6 years of age, refusal of one of the parents, and dermatosis of the scalp

Information from the National Library of Medicine

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


Contacts
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Contact: Fabrice WALLOIS, MD, PhD +33 3 22 08 77 77 wallois.fabrice@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Fabrice WALLOIS, MD, PhD    +33 3 22 08 77 77    wallois.fabrice@chu-amiens.fr   
Fondation Ophtalmologique Rothshild Recruiting
Paris, France, 75019
Contact: Mathilde CHIPEAU, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Fabrice WALLOIS, MD, PhD CHU Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02899832    
Other Study ID Numbers: PI2012_843_0029
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
children
spasms
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases