Recruiting

MigraineMigraine in Adolescents

Sponsor:

Washington University School of Medicine

Code:

NCT05654012

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 10 - 13

Healthy Volunteers: Accepted

Interventions

MRI

Thermal Stimuli

Pressure stimuli

Pain ratings

Pressure pain thresholds (PPT)

Study Details

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.

Conditions

Migraine

Study ID

NCT05654012

Start date

Jun 1, 2023

Status verified date

Jul, 2026

Completion date

Mar 15, 2030

Anticipated

Primary completion date

Mar 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 10 - 13

Healthy Volunteers: Accepted

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 Design

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Family History of Migraine

This group has a first degree relative diagnosed with migraine.

other: No Family History of Migraine

This group does not have a first or second degree relative diagnosed with migraine.

Interventions

MRI

Grey Matter Volume (T1) Resting state BOLD

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.

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.

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'').

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.

Conditioned pain modulation (CPM) efficiency

The CPM paradigm assesses endogenous inhibitory pain modulation efficiency related to spatial filtering of nociceptive information.

Hormonal assessment

Blood samples will be collected for analyses of sex hormone levels

Migraine-related measures

Adolescents with migraine will complete questions regarding their headache frequency and migraine symptoms.

Neural assessments

MRI and fMRI scans

Pubertal status

Pubertal status will be assessed using the self-reported Physical Developmental Scale-

Primary outcome measure

Number of participants with a new diagnosis of migraine [ Time Frame: 2 years ]
Number of participants with a new diagnosis of migraine [ Time Frame: 2 Years ]

Central Contacts and Locations

Central contacts

Alana McMichael, MA

314-273-6194 painlab@wustl.edu

Hadas Nahman-Averbuch

314-273-6194

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Hadas Nahman-Averbuch, PhD

314-273-6194 painlab@wustl.edu

Alana McMichael, MA

314-273-6194 painlab@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-13.