NCT05654012 · Washington University School of Medicine
Migraine in Adolescents
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
MRI
Grey Matter Volume (T1) Resting state BOLD
DEVICE
Thermal Stimuli
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.
DEVICE
Pressure stimuli
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.
BEHAVIORAL
Pain ratings
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'').
BEHAVIORAL
Pressure pain thresholds (PPT)
Pressure will be increased continually and participants will be instructed to press a button the first moment they feel pain from the pressure stimulus.
BEHAVIORAL
Conditioned pain modulation (CPM) efficiency
The CPM paradigm assesses endogenous inhibitory pain modulation efficiency related to spatial filtering of nociceptive information.
DIAGNOSTIC_TEST
Hormonal assessment
Blood samples will be collected for analyses of sex hormone levels
BEHAVIORAL
Migraine-related measures
Adolescents with migraine will complete questions regarding their headache frequency and migraine symptoms.
BEHAVIORAL
Neural assessments
MRI and fMRI scans
DIAGNOSTIC_TEST
Pubertal status
Pubertal status will be assessed using the self-reported Physical Developmental Scale-
Primary outcome measures
Number of participants with a new diagnosis of migraine
Time frame: 2 years
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.
Number of participants with a new diagnosis of migraine
Time frame: 2 Years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for healthy participants:
- 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) Inclusion criteria for participants with migraine:
- 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)
Exclusion criteria
- for the healthy group:
- 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 Exclusion Criteria for the migraine group
- 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
Where
- St Louis, Missouri
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations