Migraine in Adolescents

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05654012
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 13 Years
Healthy Volunteers
Accepted

Interventions

  • 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-

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
Aug 2025
Primary completion
Mar 15, 2028
Completion
Mar 15, 2030

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Hadas Nahman-Averbuch, PhD
[email protected]
314-273-6194
Alana McMichael, MA
[email protected]
314-273-6194

Find similar trials in St Louis, MO

By condition
Migraine
By specialty
Neurology
By research site
Washington University School of Medicine· St Louis, MO

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