RecruitingNot applicable

Migraine in Adolescents

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 13 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 days, 2 years
  • Procedures mentioned: Blood draws, MRI scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study procedures involve an MRI scan, sensory testing, blood draw, meeting with a specialist to determine migraine diagnosis, and completing surveys After signing the consent/assent form, participants and their parent/legal guardian will complete surveys to ensure eligibility."
  • "Participants will be asked to complete a one-hour MRI scan and a psychophysical session which will include quantitative sensory testing (QST) assessments of pain sensitivity and inhibitory pain modulation capabilities (by testing the conditioned pain modulation response)."
  • "During the psychophysical session, participants may also complete demographic, pubertal, and other surveys."
  • "At the end of the study visit, a blood draw may be conducted and a saliva sample might be collected for analyses of sex hormone levels."
  • "For two days following each study visit, participants may be asked to complete saliva samples, preferably at the same time as the study visit, to assess sex hormone levels."
  • "Participants will complete short online monthly surveys for 2 years asking about the number of headaches in the last month, headache severity, causes for the headaches (e.g., virus), additional symptoms, and any new migraine diagnosis."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how hormones, the brain, and responses to sensations relate to when migraines start. It also looks at what may predict how migraines change over time. It is for children ages 10–13, with or without migraines.

Aim 1. To identify psychophysical and neural factors predicting migraine onset in adolescents Aim 2a. To determine hormonal, psychophysical, and neural changes associated with migraine onset. Aim 2b. To identify the temporal relationships between hormonal, psychophysical, and neural changes preceding vs. following migraine onset. Aim 3. To identify psychophysical and neural factors predicting migraine prognosis in adolescents with migraine.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All participants must be ages 10–13. Both biological males and females may join.
  • Healthy group: Must have no migraine diagnosis or symptoms.
  • Healthy group with family history: Must have a parent, sibling, or child diagnosed with migraine.
  • Healthy group without family history: Must have no close relatives diagnosed with migraine, including parents, siblings, grandparents, aunts, uncles, or half-siblings.
  • Migraine group: Must have a migraine diagnosis or migraine symptoms.
  • Migraine group: Must have had migraines for more than 6 months.
  • Migraine group: Must use no treatment to prevent migraines, or have had no changes to that treatment in the past 6 months.

Who can't join

  • Healthy group: A diagnosed long-term pain condition.
  • Migraine group: A diagnosed long-term pain condition other than migraine.
  • Both groups: A diagnosed disorder affecting the brain or nerves, development, puberty, or mental health.
  • Healthy group: Regular use of pain medicines or medicines for mental health.
  • Both groups: A reason they cannot have an MRI scan, such as metal in the body or fear of enclosed spaces.
  • Both groups: Cannot understand and communicate in English.
  • The study doctor will decide whether these reasons prevent someone from joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria for healthy participants: 1. Age 10-13 2. Males or females (biological sex) 3. Not diagnosed with migraine or having migraine symptoms 4. With a first degree relative diagnosed with migraine (for the Fam-His group) or without a first or a second degree relative diagnosed with migraine (for the No-Fam-His group) Inclusion criteria for participants with migraine: 1. Age 10-13 2. Males or females (biological sex) 3. Diagnosed with migraine or having migraine symptoms 4. Migraine duration \> 6 months 5. Without preventative treatment or with stable preventative treatment for migraine (no change in intervention in the last 6 months) Exclusion Criteria for the healthy group: * Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion: 1. Diagnosis of any chronic pain syndrome 2. Diagnosis of a neurological, developmental, pubertal, or psychiatric disorder 3. Taking pain or psychiatric medications regularly 4. Having an MRI contraindication such as metal in the body or claustrophobia 5. Not able to understand and communicate in English Exclusion Criteria for the migraine group * Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion: 1. Diagnosis of any chronic pain syndrome other than migraine 2. Diagnosis of a neurological, developmental, pubertal, or psychiatric disorder 3. Having an MRI contraindication such as metal in the body or claustrophobia 4. Not able to understand and communicate in English

Study sites (1)

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