Migraine in Adolescents
Recruiting · NCT05654012 · Interventional (participants receive a specific treatment) · Lead sponsor: Washington University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Conditioned pain modulation (CPM) efficiencyHormonal assessmentMRIMigraine-related measuresNeural assessmentsPain ratingsPressure pain thresholds (PPT)Pressure stimuliPubertal statusThermal Stimuli
What this trial is about
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.
Who can take part
Age range
10 Years to 13 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- for healthy participants:
- Age 10-13
- Males or females (biological sex)
- Not diagnosed with migraine or having migraine symptoms
- With a first degree relative diagnosed with migraine (for the Fam-His group) or without a first or a second degree relative diagnosed with migraine (for the No-Fam-His group)
- Inclusion criteria for participants with migraine:
- Age 10-13
- Males or females (biological sex)
- Diagnosed with migraine or having migraine symptoms
- Migraine duration \> 6 months
- Without preventative treatment or with stable preventative treatment for migraine (no change in intervention in the last 6 months)
Exclusion criteria
- for the healthy group:
- Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
- Diagnosis of any chronic pain syndrome
- Diagnosis of a neurological, developmental, pubertal, or psychiatric disorder
- Taking pain or psychiatric medications regularly
- Having an MRI contraindication such as metal in the body or claustrophobia
- Not able to understand and communicate in English
- Exclusion Criteria for the migraine group
- Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
- Diagnosis of any chronic pain syndrome other than migraine
- Diagnosis of a neurological, developmental, pubertal, or psychiatric disorder
- Having an MRI contraindication such as metal in the body or claustrophobia
- Not able to understand and communicate in English
Where it is running
1 location listed across 1 US state.
- Washington University School of Medicine - St Louis, Missouri, United States