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Online Intervention for Migraines

Phase 2

Recruiting

Led By Kevin Hommel, PhD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of migraine using current International Classification of Headache Disorders Criteria (ICHD-3) for migraine with or without aura

Frequency of 8 or more headaches per month

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

Study Summary

This trial is testing whether an online intervention can help improve headache outcomes for adolescents with migraines, compared to an attention control intervention. The primary outcome will be the number of headache days, assessed via online daily diary pre- and post-intervention.

Who is the study for?

This trial is for young people aged 11 to 17 who have migraines, with at least 8 headache days per month. They must be diagnosed according to the International Classification of Headache Disorders and need internet access. Those with developmental disorders or serious mental illnesses are not eligible.Check my eligibility

What is being tested?

The Migraine Manager clinical trial tests an online program designed to help adolescents manage their migraines by promoting healthy habits like staying hydrated, eating regularly, exercising, and getting enough sleep against a control group.See study design

What are the potential side effects?

Since the intervention is non-medical and focuses on lifestyle management through an online platform, there are no direct medical side effects associated with it. However, individual experiences may vary based on adherence and personal health changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with migraine, with or without aura.

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I experience 8 or more headaches a month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Headache frequency

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Migraine ManagerExperimental Treatment1 Intervention

The Migraine Manager portal intervention is comprised of 16 modules that are assigned in an individually tailored manner to participants based on their answers to a brief assessment battery. Once assessments are completed, a treatment plan consisting of recommended modules is automatically generated for patient and parent guidance, and the user is directed to the list of recommended modules. Participants will also complete online daily diaries for eight weeks.

Group II: Attention ControlActive Control1 Intervention

Participants in this arm will complete the online daily diaries for eight weeks (i.e., equal time as the Migraine Manager arm) through the portal but will be restricted from receiving intervention content; they will also receive equal number of communications via the portal as the Migraine Manager arm. Data from migraine daily diaries will not be available to AC participants or their clinicians as this would likely be used clinically and lead to contamination of the control arm resulting from varying levels of intervention across participants based on their data.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,436 Total Patients Enrolled

6 Trials studying Migraine

2,143 Patients Enrolled for Migraine

Susan LeCates, MSN, FNPStudy ChairChildren's Hospital Medical Center, Cincinnati

Scott Powers, PhDStudy ChairChildren's Hospital Medical Center, Cincinnati

3 Previous Clinical Trials

815 Total Patients Enrolled

3 Trials studying Migraine

815 Patients Enrolled for Migraine

Media Library

Migraine Manager Clinical Trial Eligibility Overview. Trial Name: NCT04567355 — Phase 2

Migraine Research Study Groups: Migraine Manager, Attention Control

Migraine Clinical Trial 2023: Migraine Manager Highlights & Side Effects. Trial Name: NCT04567355 — Phase 2

Migraine Manager 2023 Treatment Timeline for Medical Study. Trial Name: NCT04567355 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria would be preferable for eligible participants in this medical experiment?

"This clinical trial seeks 160 minors with a diagnosis of migraines. Eligible participants need to be between the ages 11 and 17 for consideration in this study."

Answered by AI

Is there still availability for participants in this medical trial?

"This clinical trial is actively recruiting, as evidenced on clinicialtrials.gov, with the initial post date of June 10th 2021 and a recent update occurring April 11th 2022."

Answered by AI

Would geriatric individuals be included in this experiment?

"Patients aged between 11 and 17 are being recruited for this research endeavour."

Answered by AI

How many test subjects are being monitored for this experiment?

"Affirmative. The clinical trial is actively recruiting, as indicated by the data on clinicaltrials.gov; this investigation was initially posted on June 10th 2021 and has been updated recently in April 11th 2022. 160 participants will be enrolled from a single site."

Answered by AI