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Hormones and Pain Sensitivity for Migraine (IHS Trial)

N/A
Recruiting
Led By Hadas Nahman-Averbuch, PhD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline

Summary

This trial studies how hormones affect pain and migraine severity in both men and women.

Who is the study for?
This study is for boys and girls aged 11-15 who speak English. It includes two groups: one with adolescents diagnosed with migraines, and a control group of healthy individuals without a family history of migraines. Pregnant or breastfeeding teens, those with chronic pain (other than migraines), neurological issues, psychiatric conditions, or on hormone-altering meds can't participate.
What is being tested?
The trial examines how puberty hormones affect pain sensitivity and migraine severity in adolescents. Participants will undergo tests using thermal and pressure stimuli to measure pain response, complete a migraine disability assessment (PedMIDAS), have their hormonal levels checked, and assess pubertal status.
What are the potential side effects?
Since the interventions involve non-invasive testing methods like temperature exposure, pressure application, questionnaires about headaches impact on daily life (PedMIDAS) rather than medication or invasive procedures; significant side effects are not expected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Conditioned pain modulation (CPM) response
Sex Hormones
Secondary study objectives
Migraine specific measures
Sex hormone assessments

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MigraineActive Control8 Interventions
Adolescents with a migraine diagnosis
Group II: Healthy controlPlacebo Group7 Interventions
Adolescents without a migraine diagnosis

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,765 Total Patients Enrolled
1 Trials studying Migraine
250 Patients Enrolled for Migraine
International Headache SocietyUNKNOWN
2 Previous Clinical Trials
272 Total Patients Enrolled
Hadas Nahman-Averbuch, PhDPrincipal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
570 Total Patients Enrolled
1 Trials studying Migraine
250 Patients Enrolled for Migraine

Media Library

Migraine Clinical Trial Eligibility Overview. Trial Name: NCT05738213 — N/A
Migraine Research Study Groups: Migraine, Healthy control
Migraine Clinical Trial 2023: Migraine Highlights & Side Effects. Trial Name: NCT05738213 — N/A
Migraine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05738213 — N/A
~4 spots leftby Jan 2025
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