Adolescents With Migraine: What's Stress Got To Do With It? (Adostress)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Colorado Children's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Cases
Children with migraines will be placed into this group.
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Controls
Children without migraines or headaches will be placed into this group.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Correlation between hair cortisol and perceived stress
Lasso di tempo: 12 weeks
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Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires).
We expect a positive correlation.
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12 weeks
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Correlation between headache frequency, perceived stress, and hair cortisol.
Lasso di tempo: 12 weeks
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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.
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12 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Sita Kedia, MD, University of Colorado, Denver
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 13-3128
- UL1TR001082 (Sovvenzione/contratto NIH degli Stati Uniti)
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