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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
Awards & highlights
IHS Trial 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.Check my eligibility
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.See study design
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.
IHS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Conditioned pain modulation (CPM) response
Sex Hormones
Secondary outcome measures
Migraine specific measures
Sex hormone assessments
IHS 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
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,710 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 11 and 15 years old.I have chronic pain, but not migraines, or any neurological or psychiatric conditions.I am either male or female.I have been diagnosed with migraine.I am healthy and have no close relatives with migraines.I am taking medication that affects my hormone levels.
Research Study Groups:
This trial has the following groups:- Group 1: Migraine
- Group 2: Healthy control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age criteria for this research encompass octogenarians?
"For this medical trial, only individuals aged 11 to 15 years old may be accepted as participants."
Answered by AI
Are any individuals being enrolled in this clinical experiment at present?
"Per the clinicaltrials.gov website, this study is actively seeking participants; it was initially posted on January 10th of 2023 and recently modified on February 20th of that same year."
Answered by AI
Who meets the criteria for enrollment in this clinical trial?
"This study is seeking 100 pre-adolescent females, aged 11 to 15 who are fluent in English and either suffering from migraine or healthy without any diagnosis."
Answered by AI
How many participants are involved in this research endeavor?
"Affirmative, the information on clinicaltrials.gov verifies that this medical experiment is presently enrolling candidates. This endeavor was first put up on 1/10/2023 and updated most recently on 2/20/2023. The trial requires 100 participants to be admitted from a single location."
Answered by AI
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