Determining the Utility of a Behavioral Intervention in Chronic Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
have chronic migraine for a minimum of 1-year
aged 18 years and older
Disqualifiers
other headache disorders including secondary headache disorders
children younger than 18 years old
current pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Lifestyle Behavior Protocol
BehavioralVirtual training on building a skillset to improve lifestyle behavior that reduces migraine attacks
Sham Behavior Protocol
BehavioralVirtual training on the disease of migraine and how migraine can progress to chronic migraine.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Virtual Therapy GroupActive comparator 1 intervention
Group B: Attention Placebo GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Interested Participants that are Enrolled
Recruitment rate (Feasibility Outcome)
Time frame
12 weeks2
Acceptability
Retention rate
Time frame
12 weeksSecondary outcomes
1
Mean change from baseline monthly migraine frequency
Change in the mean of monthly migraine frequency
Time frame
12 weeks2
Migraine severity
severity of migraine attacks rated from 0 to 10
Time frame
12 weeksOther outcomes
1
Headache self-efficacy
Headache self-efficacy measured using the validated Headache Self-Efficacy Questionnaire. Scores range from 25 to 175. Higher scores mean a better outcome.
Time frame
12 weeks2
Levels of candidate biomarkers
Using mass spectrometry, serum levels of candidate biomarkers acryloyl-CoA, glutaminylhistidine, HABP2 will be compared at baseline and end of study (end of week-12)
Time frame
12 weeksSponsors and contacts
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Mayo Clinic
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov