Clinical Features Contributing to Cortical Thickness Changes in Chronic Migraine - A Pilot Study.
Yohannes W Woldeamanuel, Danielle D DeSouza, Bharati M Sanjanwala...
https://pubmed.ncbi.nlm.nih.gov/30468246/Actively Recruiting
Led by Mayo Clinic · Updated on 2026-06-08
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are evaluating a lifestyle behavior protocol to manage chronic migraine. This pilot study aims to assess how feasible and acceptable this behavioral approach is for patients and to explore unique biomolecules in those who respond to the treatment. The results will help design a larger future behavioral clinical trial focused on controlling chronic migraine. Participants are randomly assigned to one of two groups a Virtual Therapy Group receiving training to improve lifestyle behaviors that may reduce migraine attacks, or an Attention Placebo Group receiving education about migraine and its progression. Both groups receive virtual training over a 12-week period to compare outcomes. During the study, researchers will monitor participation rates and acceptability of the intervention. They will also measure changes in monthly migraine frequency and migraine severity over 12 weeks. The study lasts for at least 12 weeks, with assessments focused on how well participants engage with the treatment and any changes in their migraine symptoms.
CONDITIONS
Determining the Utility of a Behavioral Intervention in Chronic Migraine
D
Dr. Yohannes W. Woldeamanuel, MD
M
Migraine Study
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Mayo Clinic
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Virtual training to improve lifestyle behaviors | Virtual training about migraine and chronification |
|---|---|---|
| What the intervention is | Virtual skill-based behavioral training focused on improving lifestyle habits that aim to reduce migraine attacks. | Virtual educational sessions about migraine disease and how migraines can become chronic, without active behavioral modification. |
| Role in the study | Active comparator arm aiming to assess the effectiveness and acceptability of virtual behavioral lifestyle modification. | Attention placebo comparator used to control for non-specific effects of virtual education and participant engagement. |
| Primary clinical purpose | Designed to teach and reinforce healthy lifestyle behaviors to reduce migraine frequency and severity. | Provides disease education but does not actively modify behavioral risk factors. |
| How it is given or performed | Delivered virtually through structured training and skill-building sessions. | Delivered virtually as informational sessions on migraine and its progression. |
| Evidence and supporting research | Regular lifestyle behavior has been associated with lower migraine prevalence and improved outcomes in chronic migraine, although evidence for virtual behavioral protocols is still emerging. | Disease education alone is not established to reduce migraine frequency or severity. |
| Important limitations | The effectiveness of virtually delivered behavioral interventions for chronic migraine relies on participant engagement and adherence. Published evidence is limited regarding long-term impact. | Comparator sessions do not include strategies to change lifestyle behaviors and may not influence migraine burden. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (virtual or in-person)
Duration - 12 weeks
Participants receive virtual behavioral training to either improve lifestyle behaviors that reduce migraine attacks or learn about migraine progression, depending on their group assignment.
Weekly virtual sessions for 12 weeks
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/26810728/Mayo Clinic
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor