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Adolescents With Migraine: What's Stress Got To Do With It? (Adostress)

6 juni 2018 bijgewerkt door: University of Colorado, Denver

The overall objective of this proposal is to better define the relationship between perceived stress, hair cortisol, and migraine in adolescents. This will be done by creating 2 arms of the study: those with migraines (cases) and those without migraines or headaches (controls). Each arm will answer several of the same questionnaires and have hair cortisol samples taken multiple times over the course of 12 weeks.

Studie Overzicht

Toestand

Voltooid

Conditie

Hoofdpijn, Migraine

Gedetailleerde beschrijving

The overall objective of this proposal is to better define the relationship between perceived stress, hair cortisol, and migraine in adolescents. Although adolescents most frequently report stress as their migraine trigger, stress measurement and treatment are usually beyond the scope of routine clinical care. Hair cortisol levels may identify stressed adolescents who need structured stress management, as well as provide objective evidence for the medical community, migraineurs (i.e. individuals who experience migraines), and their families, who may be reluctant to accept stress as a migraine factor. The rationale for this research is that scientific validation of an association between stress and migraine will inform future prevention studies in the headache field and potentially identify a stress biomarker for migraine.

This prospective study will enroll 67 adolescents (aged 13-17) with migraine and 33 adolescents without migraine for 12 weeks with the following aims:

Aim 1: Measure the relationship between hair cortisol concentration and perceived stress in adolescents with and without migraine.

Hypothesis: The association between hair cortisol and perceived stress (3 month averages) will be a positive in both adolescents with and without migraine.

Aim 2: Measure the relationship between migraine frequency with perceived stress and hair cortisol concentration in adolescents with migraine.

Hypothesis: The association between migraine frequency with (a) perceived stress and (b) hair cortisol will be positive in adolescents with migraines.

Studietype

Observationeel

Inschrijving (Werkelijk)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Colorado
  - Aurora, Colorado, Verenigde Staten, 80045
    - Colorado Children's Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

13 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

The population to be sampled is adolescents (13-17 years old) with migraines, both male and female. Migraines are common in the pediatric population with a prevalence as high as 10% in children 5-14 years old,1 and 28% in adolescents 15-19 years old (Split W, 1999).

Beschrijving

Inclusion criteria:

For Cases:

Diagnosis of Migraine as defined by the ICHD-II
At least 1 migraine per month

For Controls:

No diagnosis of Migraine as defined by ICHD-II
No diagnosis of Primary Headache Disorders as defined by ICHD-II

Exclusion Criteria for Migrainers and Non-migrainers:

A secondary headache disorder as defined by ICHD-II
A continuous headache (i.e. 24 hours a day every day)
An underlying neurological condition such as epilepsy, chiari malformation, or neurocutaneous disorder
A chronic medical illness including those illnesses that require chronic steroid use such as asthma, cancer or rheumatologic disorders
Subject has bleached hair in past 3 months.
Pubertal Tanner stage 1 or 2 (Hair cortisol concentration may depend on developmental stage; 59 Tanner staging will be performed by Dr. Kedia).
Subject is pregnant or has a positive pregnancy test.
Present psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) that, in the opinion of the site investigator, would interfere with adherence to study requirements or safe participation in the trial
Any and all other diagnoses or conditions which in the opinion of the primary investigator would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study subject.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Cases Children with migraines will be placed into this group.
Controls Children without migraines or headaches will be placed into this group.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Correlation between hair cortisol and perceived stress Tijdsspanne: 12 weeks	Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires). We expect a positive correlation.	12 weeks
Correlation between headache frequency, perceived stress, and hair cortisol. Tijdsspanne: 12 weeks	Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires) and headache frequency (as measured by a headache diary, which will measure how many days per month a child has headaches). We expect a positive correlation.	12 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Colorado, Denver

Onderzoekers

Hoofdonderzoeker: Sita Kedia, MD, University of Colorado, Denver

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Split W, Neuman W. Epidemiology of migraine among students from randomly selected secondary schools in Lodz. Headache. 1999 Jul-Aug;39(7):494-501. doi: 10.1046/j.1526-4610.1999.3907494.x.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 september 2014

Primaire voltooiing (Werkelijk)

15 september 2017

Studie voltooiing (Werkelijk)

15 oktober 2017

Studieregistratiedata

Eerst ingediend

3 oktober 2014

Eerst ingediend dat voldeed aan de QC-criteria