NCT02826915

Brief Summary

Epilepsy in children is a major public health issue. It is the first neurological disease of the child.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2010

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

8.7 years

First QC Date

July 5, 2016

Last Update Submit

August 20, 2018

Conditions

Epilepsy

Keywords

newborninfantchildEEGNIRS

Outcome Measures

Primary Outcomes (2)

  • HbO

    concentration modification (Hz) of oxygenated hemoglobin (HbO) during the interictal spikes and seizures in infants and children.

    Hour 1

  • HHb

    concentration modification (Hz) of deoxygenated hemoglobin (HHb) during the interictal spikes and seizures in infants and children.

    Hour 1

Interventions

Near Infra Red Spectroscopy (NIRS)DEVICE
Electroencephalogram (EEG)DEVICE

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The inclusion of patients in the study will be conducted by doctors of the unit of pediatric neurology, intensive care or critical care of the Amiens hospital. The purchases will be made as part of the normal management of all children who have a électroecéphalographique followed.

You may qualify if:

  • \- Any child 0-16 years with partial epilepsy and / or interictal spikes located on the standard EEG recordings.

You may not qualify if:

  • All children with severe congenital malformation
  • Any refusal of a parent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Fabrice WALLOIS, MD, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice WALLOIS, MD, PhD

CONTACT

+33 3 22 08 77 77wallois.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

July 5, 2016

First Posted

July 11, 2016

Study Start

February 5, 2010

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

FR(1)