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Behavioral Intervention
Mind-Body Intervention for Migraines
N/A
Waitlist Available
Led By Michael Donnino, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously diagnosed with migraine headache based on ICHD-3 beta criteria
Presence of migraine headaches at least 5 days per month
Must not have
Known history or suspicion of headaches due to organic cause (e.g. cancer, sinus infection, head trauma, cerebrovascular disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4, 8, 13 and 20 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a new treatment approach for chronic migraines that involves both the mind and body. The main focus is to gather information on the feasibility of the treatment protocol, which has been successful
Who is the study for?
This trial is for individuals who frequently experience chronic migraines. Participants should be interested in exploring non-medical treatments and willing to follow the study's mind-body intervention protocol. Specific eligibility details are not provided, but typically include age range, migraine frequency, and overall health status.
What is being tested?
The study is testing a mind-body intervention designed to alleviate chronic migraines. It aims to gather preliminary data on how feasible this approach is based on protocols used for similar conditions and will assess various tools for measuring its effectiveness.
What are the potential side effects?
Since the trial involves a mind-body intervention, traditional medication side effects are not expected. However, participants may experience discomfort or emotional distress related to the practice of these techniques.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with migraines.
Select...
I experience migraines on 5 or more days each month.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have headaches caused by a medical condition like cancer or sinus infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4, 8, 13 and 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4, 8, 13 and 20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
HIT-6
MIDAS
Secondary study objectives
Brief Pain Inventory Questionnaire (Short Form)
Feedback on protocol
GAMS
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mind-Body InterventionExperimental Treatment1 Intervention
A Novel Mind body technique for the intervention will be taught in lectures and group discussion sessions
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
861 Previous Clinical Trials
12,932,816 Total Patients Enrolled
7 Trials studying Chronic Pain
766 Patients Enrolled for Chronic Pain
Michael Donnino, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
7 Previous Clinical Trials
612 Total Patients Enrolled
2 Trials studying Chronic Pain
185 Patients Enrolled for Chronic Pain