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

NCT02259387 | Completed

• 2 other identifiers: 13-3128UL1TR001082
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Cases

Children with migraines will be placed into this group.

Controls

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

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Colorado Children's Hospital

Aurora, Colorado, 80045, United States

Location

Related 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. doi: 10.1046/j.1526-4610.1999.3907494.x.

  PMID: 11279934 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Hair samples for cortisol.

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sita Kedia, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 8, 2014
• Study Start: September 12, 2014
• Primary Completion: September 15, 2017
• Study Completion: October 15, 2017
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

US (1)