RecruitingNot ApplicableNCT05654012

Migraine in Adolescents


Sponsor

Washington University School of Medicine

Enrollment

250 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 10 YearsMax Age: 13 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Conditioned pain modulation (CPM) efficiency, Hormonal assessment, and others for people with migraine. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMRI

Grey Matter Volume (T1) Resting state BOLD

DEVICEThermal 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.

DEVICEPressure 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.

BEHAVIORALPain 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'').

BEHAVIORALPressure 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.

BEHAVIORALConditioned pain modulation (CPM) efficiency

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

DIAGNOSTIC_TESTHormonal assessment

Blood samples will be collected for analyses of sex hormone levels

BEHAVIORALMigraine-related measures

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

BEHAVIORALNeural assessments

MRI and fMRI scans

DIAGNOSTIC_TESTPubertal status

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


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT05654012


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