Migraine in Adolescents
3 other identifiers
interventional
250
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
December 16, 2022
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2030
August 13, 2025
August 1, 2025
4.8 years
November 28, 2022
August 12, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants with a new diagnosis of migraine
Multivariable regression analyses with baseline psychophysical, and neural factors will be used to identify predictors for migraine diagnosis and headache frequency. For Aim 1a, the primary outcome is migraine diagnosis (binary variable based on the physician's diagnosis), the independent variables are baseline PPT, CPM response, and FC of the right amygdala, and the controlling factors are race and age.
2 years
Number of participants with a new diagnosis of migraine
Multivariable regression analyses with baseline psychophysical, and neural factors will be used to identify changes related to migraine diagnosis. For Aim 1b, the primary outcome measure is headache frequency (7-day average based on the headache diary completed before the 2-year follow-up visit), the independent variable is FC of the right amygdala, the controlling factors are the time of migraine diagnosis (at 1-year or 2-year study visit), race, and age. Since all participants will be at early pubertal maturation and pre-menarche at baseline, pubertal status will not be controlled for in this aim.
2 Years
Study Arms (2)
Family History of Migraine
OTHERThis group has a first degree relative diagnosed with migraine.
No Family History of Migraine
OTHERThis group does not have a first or second degree relative diagnosed with migraine.
Interventions
Grey Matter Volume (T1) Resting state BOLD
The Thermal Sensory Analyzer (TSA-II or PATHWAY platform - Medoc, Ramat Yishai, Israel) will be used to safely deliver heat and cold stimuli. These devices can deliver relatively complex stimuli via computer control. All targeted stimulus temperatures will be less than 50°C, and participants will be free to remove their arm or leg at any time from the thermode. Noxious cold stimuli will also be delivered with a plastic water container or a water bath (FISHER, USA). Participants will be free to pull out of the water bath at any time.
Pressure stimuli will be applied by using a handheld algometer (Wagner Instruments) or the Pressure Algometer (Medoc, Ramat Yishai, Israel). These devices have a round probe that allows quantifying the amount of pressure that is being applied. The Pressure Algometer allows a real-time visual feedback to control and monitor applied pressure rates. Pressure will be applied to the lower leg, volar forearm, or trapezius.
Pain intensity and pain unpleasantness ratings will be assessed by numerical rating scale (ranging from 0- no pain/unpleasantness to- 10 or 100 the most intense/unpleasantness pain imaginable) and by mechanical and computerized visual analog scales (VAS which ranges between ''no pain sensation'' and ''most intense pain imaginable'').
Pressure will be increased continually and participants will be instructed to press a button the first moment they feel pain from the pressure stimulus.
The CPM paradigm assesses endogenous inhibitory pain modulation efficiency related to spatial filtering of nociceptive information.
Blood samples will be collected for analyses of sex hormone levels
Adolescents with migraine will complete questions regarding their headache frequency and migraine symptoms.
MRI and fMRI scans
Pubertal status will be assessed using the self-reported Physical Developmental Scale-
Eligibility Criteria
You may qualify if:
- Age 10-13
- Males or females (biological sex)
- Not diagnosed with migraine or having migraine symptoms
- 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)
- Age 10-13
- Males or females (biological sex)
- Diagnosed with migraine or having migraine symptoms
- Migraine duration \> 6 months
- Without preventative treatment or with stable preventative treatment for migraine (no change in intervention in the last 6 months)
You may not qualify if:
- Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
- Diagnosis of any chronic pain syndrome
- Diagnosis of a neurological, developmental, pubertal, or psychiatric disorder
- Taking pain or psychiatric medications regularly
- Having an MRI contraindication such as metal in the body or claustrophobia
- Not able to understand and communicate in English
- Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
- Diagnosis of any chronic pain syndrome other than migraine
- Diagnosis of a neurological, developmental, pubertal, or psychiatric disorder
- Having an MRI contraindication such as metal in the body or claustrophobia
- Not able to understand and communicate in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hadas Nahman-Averbuch, PhD
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst Prof of Anesthesiology
Study Record Dates
First Submitted
November 28, 2022
First Posted
December 16, 2022
Study Start
June 1, 2023
Primary Completion (Estimated)
March 15, 2028
Study Completion (Estimated)
March 15, 2030
Last Updated
August 13, 2025
Record last verified: 2025-08