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Behavioral Intervention
Choice - ME for Migraine (SMARTMig Trial)
N/A
Recruiting
Led By Yohannes W 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
have chronic migraine for a minimum of 1-year
aged 18 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Awards & highlights
SMARTMig Trial Summary
This trial aims to understand and improve a behavioral intervention for migraines. It will also investigate the best combinations of treatments and how people's preferences and choices can affect the trial outcomes.
Who is the study for?
This trial is for adults who have been experiencing chronic migraines for at least one year. It's designed to find the best combination of behavioral treatments.Check my eligibility
What is being tested?
The study explores various behavioral interventions for managing migraines, examining which combinations work best and how personal preferences affect outcomes.See study design
What are the potential side effects?
Since this trial focuses on behavioral treatments, there may be minimal to no physical side effects; however, participants might experience temporary increases in headache or stress during adjustment periods.
SMARTMig Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had chronic migraines for at least 1 year.
Select...
I am 18 years old or older.
SMARTMig Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility in terms of recruitment and adherence rates
Secondary outcome measures
Headache Self-efficacy
Migraine Frequency
Migraine Intensity
SMARTMig Trial Design
6Treatment groups
Active Control
Group I: Choice - MEActive Control1 Intervention
this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise
Group II: Random - MEActive Control1 Intervention
participants will be randomized to an intervention involving regular mealtime and regular timed exercise
Group III: Random - MSActive Control1 Intervention
participants will be randomized to an intervention involving regular mealtime and regular sleep
Group IV: Random - SEActive Control1 Intervention
participants will be randomized to an intervention involving regular sleep and regular timed exercise
Group V: Choice - MSActive Control1 Intervention
this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep
Group VI: Choice - SEActive Control1 Intervention
this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,565 Total Patients Enrolled
7 Trials studying Migraine
1,218 Patients Enrolled for Migraine
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,326 Total Patients Enrolled
3 Trials studying Migraine
135 Patients Enrolled for Migraine
Yohannes W Woldeamanuel, MDPrincipal InvestigatorStanford University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for potential participants in this research study?
"According to the updated information on clinicaltrials.gov, this trial is currently seeking eligible participants. The initial posting date of the trial was December 15th, 2023, and it was last edited on January 26th, 2024."
Answered by AI
What is the upper limit for the number of individuals who can participate in this clinical investigation?
"Indeed, the information available on clinicaltrials.gov indicates that this ongoing study is actively seeking participants. The trial was initially posted on December 15th, 2023 and was most recently updated on January 26th, 2024. To complete the research, a total of 24 individuals will be enrolled at a single site."
Answered by AI
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