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

Headache, Migraine Clinical Trial

— Adostress  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259387
• Other study ID #: 13-3128
• Secondary ID: UL1TR001082
• Status: Completed
• Start date: September 12, 2014
• Est. completion date: October 15, 2017

Study information

• Verified date: June 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders

Locations

Country	Name	City	State
United States	Colorado Children's Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (1)

Split W, Neuman W. Epidemiology of migraine among students from randomly selected secondary schools in Lodz. Headache. 1999 Jul-Aug;39(7):494-501. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between hair cortisol and perceived stress	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
Primary	Correlation between headache frequency, perceived stress, and hair cortisol.	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