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TerminatedNCT02799108LANGLATUpdated Jun 14, 2016

Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)

An interventional study of NIRS and fMRI in Epilepsy, sponsored by Centre Hospitalier Universitaire, Amiens. Terminated at 1 site in France. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-06-14.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Basic science

Why this study was terminated
inclusion difficulty
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
6 Years to 18 Years
Sex
All
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Study summary

Recent data published by various laboratories as well as our preliminary data tend to prove that near-infrared spectroscopy can be used to determine the lateralization of language as part of the preoperative assessment for drug-resistant epilepsy. The reference test used up until very recently was the Wada test, which consisted of injecting an anaesthetic (generally amobarbital sodium) into one of the internal carotid arteries (right or left) in order to determine the predominant cerebral hemisphere for language. This invasive test has been progressively replaced by fMRI, which is nevertheless difficult to perform in children under the age of 7 years. NIRS therefore appears to be a useful alternative, which, in contrast with fMRI, can be easily repeated and allows simple investigation of the various facets of language (e.g. expressive, receptive). In the GRAMFC unit, the investigators have acquired a unique know-how in the field of high-resolution NIRS, both in epilepsy and in the development of language structures.

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Conditions studied

  • Epilepsy

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Keywords

  • children
  • language
  • NIRS
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 4 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

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

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Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated.

Exclusion criteria

Exclusion Criteria:

  • All children with severe congenital malformation
  • Any refusal of a parent or child
  • Any child with generalized epilepsy or diffuse interictal spikes
  • Any child with a serious deterioration in the general condition and vital functions
  • Any child with dermatitis of the face or scalp
  • Children under 6 years
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    patients

    children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated

    Device: NIRS · Device: fMRI

Interventions

  • DeviceNIRS

    High-resolution EEG-fNIRS recording lasting a maximum of 30 minutes by using expressive and receptive language paradigms

  • DevicefMRI

    fMRI acquisition under the same stimulation conditions

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What researchers measure

Primary outcomes

  1. lateralization index

    Time frame: 3 months

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Study locations

1 site
  • CHU Amiens
    Amiens, 80054, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2016, 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
NCT02799108
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jun 14, 2016
Start date
May 2012
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Jun 14, 2016

Study contacts

Fabrince WALLOIS, MD,PhD
principal investigator · CHU Amiens

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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