The Effect of Child Position on the Results of Hyperventilation During Routine Electroencephalography

NCT ID: NCT02851199

Last Updated: 2016-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-12-31

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

Detailed Description

The study will include 30 patients at the age of 4-10 years old of both sexes. after signing an informed concent, every child, suspected of having absence seizures, will undergoe an EEG recording including a provocation of hyperventilation.

The study will include two groups:

1. A group of 15 children who will undergoe an EEG 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

2. A group of 15 children who will undergoe an EEG 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 prone position.

Participants who will not be able to perform all the steps of the study will be excluded 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)

Conditions

Epilepsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

study group 1

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

Group Type: ACTIVE_COMPARATOR

Electroencephalography

Intervention Type: DEVICE

Electroencephalograph recording following hyperventilation in different participant's body postures

study group 2

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

Group Type: ACTIVE_COMPARATOR

Electroencephalography

Intervention Type: DEVICE

Electroencephalograph recording following hyperventilation in different participant's body postures

Interventions

Electroencephalography

Electroencephalograph recording following hyperventilation in different participant's body postures

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hillel Yaffe medical center

Hadera, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Muhammad Mahajna, MD PHD

Role: CONTACT

mohamedm@hy.health.gov.il

972506246959

Facility Contacts

Muhammad Mahajna, MD PHD

Role: primary

mohamedm@hy.health.gov.il

972506246959

References

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.

Reference Type: BACKGROUND

PMID: 25661285 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19632158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20378290 (View on PubMed)

Other Identifiers

HYMC-0043-16

Identifier Type: -

Identifier Source: org_study_id