Migraine in Adolescents

NCT05654012 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-08-13

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05654012 on ClinicalTrials.gov