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The Prognosis of Migraine and Tension-Type Headache in Children and Adolescents

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ClinicalTrials.gov Identifier: NCT04623203
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Jacob.genizi, Bnai Zion Medical Center

Study Description
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Brief Summary:
Children and adolescents that visited the pediatric neurology clinic at the Bnai Zion medical center do to migraine or TTH headache between the years 2007-2010 were reevaluated. We used a structured headache questionnaire through a phone interview with the patients and their caregivers. Data regarding demographics, the patients' and families' medical history, and headache history, past and current (age at onset, location, quality, frequency, duration of episodes, aura, associated symptoms and treatment) were collected.

Condition or disease Intervention/treatment
Children, Only Headache, Migraine Headache, Tension Other: No intervention

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Prognosis of Migraine and Tension-Type Headache in Children and Adolescents
Actual Study Start Date : November 22, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Groups and Cohorts
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Group/Cohort Intervention/treatment
children with migraine
Children that were diagnosed at the neurology clinic with migraine at the years 2007-2010. A follow up visit at 2020 of their current headache condition.
 Other: No intervention
No intervention
children with TTH
children that were diagnosed at the neurology clinic with TTH at the years 2007-2010. A follow up visit at 2020 of their current headache condition.
 Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Headache diagnosis according to the ICHD-3 criteria [ Time Frame: 10 years from initial diagnosis ]
    The diagnosis of headache episodes at follow-up according to the ICHD-3 criteria; either Migraine or TTH.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents that visited the pediatric neurology clinic at the Bnai Zion medical center do to migraine or TTH headache between the years 2007-2010
Criteria

Inclusion Criteria:

  • Diagnosis of migraine or TTH headache according to the ICHD-3 criteria.
  • Can describe the current headache status.

Exclusion Criteria:

* Secondary headaches.

Contacts and Locations
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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): NCT04623203


Contacts
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Contact: jacob Genizi, MD 972-4-8359662 genizij@gmail.com

Locations
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Israel
Bnai Zion Medical Center Recruiting
Haifa, Israel, 3104802
Contact: Jacob Genizi, MD    972-4-8359662    genizij@gmail.com   
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
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Principal Investigator: Jacob GENIZI Bnai Zion Medical Center
More Information
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Responsible Party: Jacob.genizi, Manager pediatric neurology unit, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT04623203    
Other Study ID Numbers: BNZ 109-18
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not yer decided how

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacob.genizi, Bnai Zion Medical Center:
Headache
Migraine
Tension Type Headache
Adolescents
Outcome
Additional relevant MeSH terms:
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Migraine Disorders
Tension-Type Headache
Headache
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations