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CompletedNCT02899832SPASMES-NIRSUpdated Jun 12, 2026

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

An observational study in Epilepsy, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 2 sites in France. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
14
Ages
3 Years to 6 Years
Sex
All
01

Study 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

02

Conditions studied

  • Epilepsy

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Keywords

  • children
  • spasms
03

In context

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's enrollment of 14 is below the median of 112 across 540 observational studies indexed under Epilepsy.

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Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children between 3 and 6 years old presenting infantile spasms

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No

Groups and cohorts

  • NIRS

    Near Infra Red Spectroscopy.

    Device: NIRS

Interventions

  • DeviceNIRS

    Near Infra Red Spectroscopy

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What researchers measure

Primary outcomes

  1. changes in HbO

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

    Time frame: Day 0

  2. changes in Hbr

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

    Time frame: Day 0

07

Study locations

2 sites
  • CHU Amiens
    Amiens, 80054, France
  • Fondation Ophtalmologique Rothshild
    Paris, 75019, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02899832
Responsible party
Sponsor
First posted
Sep 14, 2016
Start date
Feb 21, 2013
Primary completion
Feb 13, 2020
Completion
Feb 13, 2020
Last update
Jun 12, 2026

Study contacts

Fabrice WALLOIS, MD, PhD
principal investigator · CHU Amiens
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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