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Behavioral Intervention for Chronic Migraine (RLB Trial)

N/A
Recruiting
Led By Yohannes Woldeamanuel, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
aged 18 years and older
Aged 18 years and older
Must not have
Children younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks

Summary

This trial will test a new protocol to manage chronic migraine and investigate biomolecules involved in chronic migraine patients who respond to the protocol.

Who is the study for?
This trial is for adults who have been experiencing chronic migraines for at least one year. It's not suitable for individuals with other types of headaches, those under 18, or pregnant women.
What is being tested?
The study is testing a lifestyle behavior protocol designed to manage chronic migraines and will compare it against a sham (placebo) protocol. The trial also aims to identify specific biomolecules related to the condition.
What are the potential side effects?
Since this is a behavioral intervention focusing on lifestyle changes rather than medication, significant side effects are not expected. However, participants may experience discomfort or stress from changing their habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am 18 years old or older.
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I have had chronic migraines for at least 1 year.
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I have had chronic migraines for at least 1 year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability
Feasibility
Secondary study objectives
Mean change from baseline monthly migraine frequency
Migraine severity
Other study objectives
Headache self-efficacy
Levels of candidate biomarkers

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Virtual Therapy GroupActive Control1 Intervention
Group II: Attention Placebo GroupPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,474 Previous Clinical Trials
17,501,870 Total Patients Enrolled
7 Trials studying Headache
3,213 Patients Enrolled for Headache
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,378 Previous Clinical Trials
652,122 Total Patients Enrolled
11 Trials studying Headache
2,250 Patients Enrolled for Headache
Yohannes Woldeamanuel, MDPrincipal InvestigatorStanford University

Media Library

Lifestyle Behavior Protocol Clinical Trial Eligibility Overview. Trial Name: NCT05415020 — N/A
Headache Research Study Groups: Virtual Therapy Group, Attention Placebo Group
Headache Clinical Trial 2023: Lifestyle Behavior Protocol Highlights & Side Effects. Trial Name: NCT05415020 — N/A
Lifestyle Behavior Protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05415020 — N/A
Headache Patient Testimony for trial: Trial Name: NCT05415020 — N/A
~21 spots leftby Nov 2025
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