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

NCT02899832 | Unknown

• 1 other identifier: PI2012_843_0029
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

children; spasms

Outcome Measures

Primary Outcomes (2)

• changes in HbO

  hemodynamic changes in \[HbO\] before spasms, during spasms, and after spasms

  Day 0

• changes in Hbr

  hemodynamic changes in \[Hbr\] before spasms, during spasms, and after spasms

  Day 0

Study Arms (1)

NIRS

Near Infra Red Spectroscopy.

Device: NIRS

Interventions

NIRS DEVICE

Near Infra Red Spectroscopy

NIRS

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between 3 and 6 years old presenting infantile spasms

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (2)

CHU Amiens

Amiens, 80054, France

RECRUITING

Fondation Ophtalmologique Rothshild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Epilepsy; Spasm

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabrice WALLOIS, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice WALLOIS, MD, PhD

CONTACT

+33 3 22 08 77 77; wallois.fabrice@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 14, 2016
• Study Start: February 21, 2013
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

FR (2)