Migraine in Adolescents

ConditionMigraine

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age10-13

SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

MRI
Device
Grey Matter Volume (T1) Resting state BOLD
Thermal Stimuli
Device
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
Device
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
Behavioral
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)
Behavioral
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
Behavioral
The CPM paradigm assesses endogenous inhibitory pain modulation efficiency related to spatial filtering of nociceptive information.
Hormonal assessment
Diagnostic test
Blood samples will be collected for analyses of sex hormone levels
Migraine-related measures
Behavioral
Adolescents with migraine will complete questions regarding their headache frequency and migraine symptoms.
Neural assessments
Behavioral
MRI and fMRI scans
Pubertal status
Diagnostic test
Pubertal status will be assessed using the self-reported Physical Developmental Scale-

Treatment groups

250 Participants

are divided into 2 treatment groups

Group A: Family History of MigraineOther 10 interventions

Group B: No Family History of MigraineOther 10 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

2 Years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov

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