NCT02851199

Brief Summary

Electroencephalograhy (EEG) is used as a tool for diagnosing epilepsy/convulsions. During the recording, especially for childen who are suspected of having abbcence epilepsy the investigators will perform an EEG recording including a provocation test of hyperventilation in order to induce epileptic discharges. There is no clear instruction about the position of the child during performing this hyperventilation provocation. Clinical observations showed that this provocation is more effective when it's performed in the siiting position. No study was previously performed to investigate this issue

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

July 28, 2016

Last Update Submit

August 2, 2016

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • epileptic discharge measurement

    The analysis of the study results will be performed by a specialist in pediatric neurology and pediatric epilepsy who will confirm whether the EEG recording show epileptic discharge (sharp waves, slow waves, combination of sharp and slow waves, spikes or combination of spikes and slow waves)

    1 day

Study Arms (2)

study group 1

ACTIVE COMPARATOR

1\. A group of 15 children who will undergoe an electroencephlaography recording with 3 minutes of hyperventilation in the prone position, followed by 5 minutes of rest, then after another 5-10 minutes of recording with normal breathing. Finally the participants will performed additional 3 minutes of hyperventilation in the sitting position

Device: Electroencephalography

study group 2

ACTIVE COMPARATOR

2\. A group of 15 children who will undergoe an electroencephlaography recording with 3 minutes of hyperventilation in the sitting position, followed by 5 minutes of rest, then after another 5-10 minutes of recording with normal breathing. . Finally the participants will performed additional 3 minutes of hyperventilation in the

Device: Electroencephalography

Interventions

ElectroencephalographyDEVICE

Electroencephalograph recording following hyperventilation in different participant's body postures

study group 1study group 2

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children suspected of having absence seizures in the ages mentioned above.
  • legal guardian approval

You may not qualify if:

  • inability to perform hyperventilation
  • children who have absence seizure under anti-convulsive treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, 38100, Israel

RECRUITING

Related Publications (3)

  • Watemberg N, Farkash M, Har-Gil M, Sezer T, Goldberg-Stern H, Alehan F. Hyperventilation during routine electroencephalography: are three minutes really necessary? Pediatr Neurol. 2015 Apr;52(4):410-3. doi: 10.1016/j.pediatrneurol.2014.12.003. Epub 2014 Dec 31.

    PMID: 25661285BACKGROUND

  • Hughes JR. Absence seizures: a review of recent reports with new concepts. Epilepsy Behav. 2009 Aug;15(4):404-12. doi: 10.1016/j.yebeh.2009.06.007. Epub 2009 Jul 24.

    PMID: 19632158BACKGROUND

  • Ma X, Zhang Y, Yang Z, Liu X, Sun H, Qin J, Wu X, Liang J. Childhood absence epilepsy: Elctroclinical features and diagnostic criteria. Brain Dev. 2011 Feb;33(2):114-9. doi: 10.1016/j.braindev.2010.02.004. Epub 2010 Apr 7.

    PMID: 20378290BACKGROUND

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

Central Study Contacts

Muhammad Mahajna, MD PHD

CONTACT

972506246959mohamedm@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 1, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

August 3, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

IL(1)