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

NCT ID: NCT02899832

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-21
• Study Completion Date: 2020-02-29

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

Conditions

Epilepsy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

NIRS

Near Infra Red Spectroscopy.

NIRS

Intervention Type: DEVICE

Near Infra Red Spectroscopy

Interventions

NIRS

Near Infra Red Spectroscopy

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrice WALLOIS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens

Amiens, , France

Site Status: RECRUITING

Fondation Ophtalmologique Rothshild

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Fabrice WALLOIS, MD, PhD

Role: CONTACT

wallois.fabrice@chu-amiens.fr

+33 3 22 08 77 77

Facility Contacts

Fabrice WALLOIS, MD, PhD

Role: primary

wallois.fabrice@chu-amiens.fr

+33 3 22 08 77 77

Mathilde CHIPEAU, MD

Role: primary

Other Identifiers

PI2012_843_0029

Identifier Type: -

Identifier Source: org_study_id