Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Concomitant High-resolution Recording of Haemodynamic and Electrical Activities of Children With Typical or Atypical Absence Seizures (Absence)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02819427
Recruitment Status : Active, not recruiting
First Posted : June 30, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

This study, conducted in children with typical or atypical "absence" epilepsy, will consist of noninvasive recording of the metabolic activity of the brain concomitantly with electroencephalographic recording during seizures without the need for any additional examination. This examination will be performed by combining near-infrared spectroscopy (NIRS) optical imaging and Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording.

Surface electroencephalography (EEG) is a valuable tool to assess neuronal dysfunction from a functional point of view and is used in the routine follow-up of epileptic children. Optical imaging is a recent and promising medical imaging technique, which uses near-infrared light. This rapid, noninvasive and harmless quantitative technique can be easily used at the child's bedside or in the ward and provides metabolic information on brain functioning.


Condition or disease Intervention/treatment
Epilepsy Device: Near Infra Red Spectroscopy (NIRS) Device: Electroencephalography (EEG)

Layout table for study information
Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Concomitant High-resolution Recording of Haemodynamic and Electrical Activities of Children With Typical or Atypical Absence Seizures: Near-infrared Spectroscopy (NIRS) Coupled to Electroencephalography (EEG)
Study Start Date : April 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Group/Cohort Intervention/treatment
epilepsy
children with absence epilepsy presenting either typical or atypical seizures
Device: Near Infra Red Spectroscopy (NIRS)
Device: Electroencephalography (EEG)
Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording.




Primary Outcome Measures :
  1. haemodynamic changes [ Time Frame: Day 0 ]
    haemodynamic changes by optical imaging, during the 4 interictal, preictal, ictal and postictal phases of absence seizures as defined by EEG analysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children with absence epilepsy presenting either typical or atypical seizures
Criteria

Inclusion Criteria:

  • Children aged 3 to 14 years
  • Featuring absence epilepsy with typical or atypical seizures characterized by the presence of spontaneous spike-wave flashes with standard EEG

Exclusion Criteria:

  • All children with severe congenital malformation
  • Any refusal of a parent or child
  • Any child with a serious deterioration in the general condition and vital functions
  • Any child with dermatitis of the face or scalp
  • Children under 3 years old or over 14 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819427


Locations
Layout table for location information
France
CHU Amiens
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Layout table for investigator information
Principal Investigator: Fabrice WALLOIS, MD, PhD CHU Amiens

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02819427     History of Changes
Other Study ID Numbers: PI2012_843_0025
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Spectroscopy, Near-Infrared
Electroencephalography
children
Additional relevant MeSH terms:
Layout table for MeSH terms
Seizures
Epilepsy, Absence
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Epilepsy, Generalized
Epileptic Syndromes