Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02899832
Acronym
SPASMES-NIRS
Enrollment
14
Registered
2016-09-14
Start date
2013-02-21
Completion date
2020-02-13
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

children, spasms

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

Interventions

DEVICENIRS

Near Infra Red Spectroscopy

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
changes in HbODay 0hemodynamic changes in \[HbO\] before spasms, during spasms, and after spasms
changes in HbrDay 0hemodynamic changes in \[Hbr\] before spasms, during spasms, and after spasms

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFabrice WALLOIS, MD, PhD

CHU Amiens

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026