Migraine in Adolescents

NARecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

March 15, 2028

Study Completion Date

March 15, 2030

Conditions
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-

Trial Locations (1)

63110

RECRUITING

Washington University School of Medicine, St Louis

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

Washington University School of Medicine

OTHER