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

NCT ID: NCT02259387

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-12
• Study Completion Date: 2017-10-15

Brief Summary

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.

Detailed Description

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.

Conditions

Headache, Migraine

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

Children with migraines will be placed into this group.

No interventions assigned to this group

Controls

Children without migraines or headaches will be placed into this group.

No interventions assigned to this group

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sita Kedia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Colorado Children's Hospital

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11279934 (View on PubMed)

Other Identifiers

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-3128

Identifier Type: -

Identifier Source: org_study_id