Migraine in Adolescents
NCT05654012 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2025-08-13
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
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-
Sponsors & Collaborators
-
National Institute of Neurological Disorders and Stroke (NINDS)
collaborator NIH -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Hadas Nahman-Averbuch, PhD · Washington University School of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-01
- Primary Completion
- 2028-03-15
- Completion
- 2030-03-15
Countries
- United States
Study Locations
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