Puberty, Sex Hormones and Pain Sensitivity in Adolescents With Migraine (IHS)

The Washington University

Status: Active, not recruiting

Conditions: Migraine

Treatments: Diagnostic Test: Hormonal assessment; Behavioral: PedMIDAS (Pediatric Migraine Disability Assessment); Behavioral: Conditioned pain modulation (CPM) response; Device: Pressure stimuli; Device: Thermal stimuli; Other: Pubertal status; Behavioral: Pain ratings; Behavioral: Pressure pain thresholds (PPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05738213

202208057

Seed Pediatric Research Grant (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this research study is to investigate the relationships between sex hormone levels and experimental pain sensitivity and migraine severity will be examined.

Full description

This study will investigate how puberty and variability in sex hormone levels impact pain sensitivity and migraine symptoms.

Hypothesis 1- A significant reduction in pain sensitivity from early to late pubertal status will be found only for adolescents without but not with migraine during pubertal maturation.

Hypothesis 2- Experimental pain sensitivity will be negatively correlated with testosterone levels in adolescents in both groups (with and without migraine).

Exploratory Hypothesis 1- In adolescents with migraine, higher migraine severity (headache frequency and migraine disability) will be associated with lower testosterone levels.

Exploratory hypothesis 2- Adolescents with migraine will have lower testosterone levels than those without.

Enrollment: 100 estimated patients

Sex: All

Ages: 11 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Age between 11-15
2. Males and females
3. English speakers
4. Migraine group: diagnosed with migraine
5. Control group: Healthy, with no first degree relative with migraine

Exclusion criteria:

1. Pregnancy or breastfeeding,
2. Chronic pain (except for migraine for the migraine group), neurological or psychiatric syndromes or syndromes associated with pubertal maturation
3. Use of medications that impact sex hormone levels (i.e., contraceptive pills)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Migraine

Active Comparator group

Description:

Adolescents with a migraine diagnosis

Treatment:

Behavioral: Pressure pain thresholds (PPT)

Other: Pubertal status

Behavioral: Pain ratings

Device: Pressure stimuli

Device: Thermal stimuli

Behavioral: Conditioned pain modulation (CPM) response

Behavioral: PedMIDAS (Pediatric Migraine Disability Assessment)

Diagnostic Test: Hormonal assessment

Healthy control

Placebo Comparator group

Description:

Adolescents without a migraine diagnosis

Treatment:

Behavioral: Pressure pain thresholds (PPT)

Other: Pubertal status

Behavioral: Pain ratings

Device: Pressure stimuli

Device: Thermal stimuli

Behavioral: Conditioned pain modulation (CPM) response

Diagnostic Test: Hormonal assessment