MigraineNCT05654012
Migraine in Adolescents
A study testing MRI, Thermal Stimuli and Pressure stimuli in people with Migraine, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- MRI, Thermal Stimuli and Pressure stimuli
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 15 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Show all 9Show fewer
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hadas Nahman-Averbuch contact
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Hadas Nahman-Averbuch, PhD, 314-273-6194, painlab@wustl.edu
Alana McMichael, MA, 314-273-6194, painlab@wustl.edu
About this study
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.
Read the detailed description
This study aims to identify predictors of migraine onset in adolescents as well as to determine hormonal, psychophysical, and neural changes associated with migraine onset. 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. At the beginning and/or after the baseline study visit and the beginning and/or after the follow-up study visits, participants will meet (in person or via electronic communication) with a headache/ pain specialist or a trained study staff member to determine if they meet the criteria for migraine diagnosis (based on the International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria). Participants will receive a copy of the Migraine Physician Meeting Summary Form (Migraine Summary Form). This may be sent to their email directly, email via DocuSign or in person at a study visit. For the healthy group, participants are required not to meet the criteria for migraine at the baseline study visit. For the migraine group, participants are required to meet the criteria for migraine diagnosis or present with migraine symptoms at the baseline study visit. 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. Additional blood and/or saliva samples may be collected at the study visits and stored for future genetic, hormonal or immune analyses.
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.
After 1 and 2 years, participants will return for follow-up study visits which may include the same procedures (MRI session, psychophysical session, completing surveys and a blood draw, and meeting with a headache/ pain specialist/trained study staff member).
Post menarche participants may have a pregnancy test before initiation of the study visit procedures. In case of pregnancy, participants will only meet with the headache/ pain specialist/trained study staff member and complete surveys. In addition, for post-menarche participants, if possible, the follow-up study visits may be scheduled at the follicular phase of the menstrual cycle (1-10 days after the beginning of menstruation).
If participants meet the diagnosis criteria for migraine at the follow-up study visits, they may be asked to complete additional surveys regarding their headaches characteristics (e.g., headache duration, intensity, and treatments, following the NINDS Common Data Elements,[2] and migraine-related disability which is widely used in pediatric patients.[43; 44] 28 days before and/or after the baseline and follow-up study visits, participants may be asked to complete a daily headache diary to assess headache frequency.
All study procedures are optional and participates can stop or not complete tests if they want.
- Conditions
- Migraine
- Being tested
- MRI, Thermal Stimuli, Pressure stimuli, Pain ratings, Pressure pain thresholds (PPT)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Grey Matter Volume (T1) Resting state BOLD
Thermal StimuliDevice
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 stimuliDevice
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 ratingsBehavioural
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 pain thresholds (PPT)Behavioural
Pressure will be increased continually and participants will be instructed to press a button the first moment they feel pain from the pressure stimulus.
Conditioned pain modulation (CPM) efficiencyBehavioural
The CPM paradigm assesses endogenous inhibitory pain modulation efficiency related to spatial filtering of nociceptive information.
Hormonal assessmentDiagnostic test
Blood samples will be collected for analyses of sex hormone levels
Migraine-related measuresBehavioural
Adolescents with migraine will complete questions regarding their headache frequency and migraine symptoms.
Neural assessmentsBehavioural
MRI and fMRI scans
Pubertal statusDiagnostic test
Pubertal status will be assessed using the self-reported Physical Developmental Scale-
| Study group | Role | What they receive |
|---|---|---|
| Family History of Migraine | Other | This group has a first degree relative diagnosed with migraine. Receives: Device: MRI; Device: Thermal Stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Pressure pain thresholds (PPT); Behavioral: Conditioned pain modulation (CPM) efficiency; Diagnostic Test: Hormonal assessment; Behavioral: Migraine-related measures; Behavioral: Neural assessments; Diagnostic Test: Pubertal status |
| No Family History of Migraine | Other | This group does not have a first or second degree relative diagnosed with migraine. Receives: Device: MRI; Device: Thermal Stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Pressure pain thresholds (PPT); Behavioral: Conditioned pain modulation (CPM) efficiency; Diagnostic Test: Hormonal assessment; Behavioral: Migraine-related measures; Behavioral: Neural assessments; Diagnostic Test: Pubertal status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Jun 2023
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Hadas Nahman-Averbuch, Washington University School of Medicine
- Investigators
- Hadas Nahman-Averbuch, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654012
- Sponsor's protocol ID
- 202208056
- Other IDs
- R01NS134986, R01NS129742
- Status last verified
- Jul 2026
- First submitted
- 28 Nov 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine in Adolescents
- ClinicalTrials.gov ID
- NCT05654012
- Acronym / sponsor ID
- 202208056
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2030 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to identify predictors of migraine onset in adolescents as well as to determine hormonal, psychophysical, and neural changes associated with migraine onset. 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. At the beginning and/or after the baseline study visit and the beginning and/or after the follow-up study visits, participants will meet (in person or via electronic communication) with a headache/ pain specialist or a trained study staff member to determine if they meet the criteria for migraine diagnosis (based on the International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria). Participants will receive a copy of the Migraine Physician Meeting Summary Form (Migraine Summary Form). This may be sent to their email directly, email via DocuSign or in person at a study visit. For the healthy group, participants are required not to meet the criteria for migraine at the baseline study visit. For the migraine group, participants are required to meet the criteria for migraine diagnosis or present with migraine symptoms at the baseline study visit. 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. Additional blood and/or saliva samples may be collected at the study visits and stored for future genetic, hormonal or immune analyses.
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.
After 1 and 2 years, participants will return for follow-up study visits which may include the same procedures (MRI session, psychophysical session, completing surveys and a blood draw, and meeting with a headache/ pain specialist/trained study staff member).
Post menarche participants may have a pregnancy test before initiation of the study visit procedures. In case of pregnancy, participants will only meet with the headache/ pain specialist/trained study staff member and complete surveys. In addition, for post-menarche participants, if possible, the follow-up study visits may be scheduled at the follicular phase of the menstrual cycle (1-10 days after the beginning of menstruation).
If participants meet the diagnosis criteria for migraine at the follow-up study visits, they may be asked to complete additional surveys regarding their headaches characteristics (e.g., headache duration, intensity, and treatments, following the NINDS Common Data Elements,[2] and migraine-related disability which is widely used in pediatric patients.[43; 44] 28 days before and/or after the baseline and follow-up study visits, participants may be asked to complete a daily headache diary to assess headache frequency.
All study procedures are optional and participates can stop or not complete tests if they want.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family History of Migraine | Other | Device: MRI, Device: Thermal Stimuli, Device: Pressure stimuli, Behavioral: Pain ratings, Behavioral: Pressure pain thresholds (PPT), Behavioral: Conditioned pain modulation (CPM) efficiency, Diagnostic Test: Hormonal assessment, Behavioral: Migraine-related measures, Behavioral: Neural assessments, Diagnostic Test: Pubertal statusThis group has a first degree relative diagnosed with migraine. |
| No Family History of Migraine | Other | Device: MRI, Device: Thermal Stimuli, Device: Pressure stimuli, Behavioral: Pain ratings, Behavioral: Pressure pain thresholds (PPT), Behavioral: Conditioned pain modulation (CPM) efficiency, Diagnostic Test: Hormonal assessment, Behavioral: Migraine-related measures, Behavioral: Neural assessments, Diagnostic Test: Pubertal statusThis group does not have a first or second degree relative diagnosed with migraine. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
- Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIGrey Matter Volume (T1) Resting state BOLD | Device | Family History of Migraine, No Family History of Migraine |
| Thermal StimuliThe 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 | Family History of Migraine, No Family History of Migraine |
| Pressure stimuliPressure 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. | Device | Family History of Migraine, No Family History of Migraine |
| Pain ratingsPain 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''). | Behavioural | Family History of Migraine, No Family History of Migraine |
| 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. | Behavioural | Family History of Migraine, No Family History of Migraine |
| Conditioned pain modulation (CPM) efficiencyThe CPM paradigm assesses endogenous inhibitory pain modulation efficiency related to spatial filtering of nociceptive information. | Behavioural | Family History of Migraine, No Family History of Migraine |
| Hormonal assessmentBlood samples will be collected for analyses of sex hormone levels | Diagnostic test | Family History of Migraine, No Family History of Migraine |
| Migraine-related measuresAdolescents with migraine will complete questions regarding their headache frequency and migraine symptoms. | Behavioural | Family History of Migraine, No Family History of Migraine |
| Neural assessmentsMRI and fMRI scans | Behavioural | Family History of Migraine, No Family History of Migraine |
| Pubertal statusPubertal status will be assessed using the self-reported Physical Developmental Scale- | Diagnostic test | Family History of Migraine, No Family History of Migraine |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hadas Nahman-Averbuch contact
Hadas Nahman-Averbuch, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, Thermal Stimuli and Pressure stimuli in people with Migraine, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alana McMichael, MA (314-273-6194, painlab@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a new diagnosis of migraine (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.