Adolescents With Migraine: What's Stress Got To Do With It? (Adostress)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Colorado Children's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation between hair cortisol and perceived stress
Periodo de tiempo: 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.
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sita Kedia, MD, University of Colorado, Denver
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13-3128
- UL1TR001082 (Subvención/contrato del NIH de EE. UU.)
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