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A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms (SPASMES-NIRS)

C

Centre Hospitalier Universitaire, Amiens

Status

Unknown

Conditions

Epilepsy

Treatments

Device: NIRS

Study type

Observational

Funder types

Other

Identifiers

NCT02899832
PI2012_843_0029

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

3 to 6 years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

NIRS
Description:
Near Infra Red Spectroscopy.
Treatment:
Device: NIRS

Trial contacts and locations

2

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Central trial contact

Fabrice WALLOIS, MD, PhD

Data sourced from clinicaltrials.gov

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