Clinical trial NCT05415020: Determining the Utility of a Behavioral Intervention in Chronic Migraine
Official title: Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Headache
Migraine Disorders
Chronic Migraine
Lifestyle Factors
Headache Disorders
Keywords: Migraine Disorders
Headache
Lifestyle
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2022-06-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* have chronic migraine for a minimum of 1-year
* aged 18 years and older

Exclusion Criteria:

* other headache disorders including secondary headache disorders
* children younger than 18 years old
* current pregnancy

Primary outcomes:
measure: Feasibility
timeFrame: 12 weeks
measure: Acceptability
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean change from baseline monthly migraine frequency
timeFrame: 12 weeks
measure: Migraine severity
timeFrame: 12 weeks
Other outcomes:
measure: Headache self-efficacy
timeFrame: 12 weeks
measure: Levels of candidate biomarkers
timeFrame: 12 weeks
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Dr. Yohannes Woldeamanuel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6.
citation: Woldeamanuel YW, Sanjanwala BM, Cowan RP. Endogenous glucocorticoids may serve as biomarkers for migraine chronification. Ther Adv Chronic Dis. 2020 Jul 21;11:2040622320939793. doi: 10.1177/2040622320939793. eCollection 2020.
citation: Woldeamanuel YW, Sanjanwala BM, Peretz AM, Cowan RP. Exploring Natural Clusters of Chronic Migraine Phenotypes: A Cross-Sectional Clinical Study. Sci Rep. 2020 Feb 18;10(1):2804. doi: 10.1038/s41598-020-59738-1.
citation: Woldeamanuel YW, DeSouza DD, Sanjanwala BM, Cowan RP. Clinical Features Contributing to Cortical Thickness Changes in Chronic Migraine - A Pilot Study. Headache. 2019 Feb;59(2):180-191. doi: 10.1111/head.13452. Epub 2018 Nov 23.
citation: Woldeamanuel YW, Cowan RP. Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants. J Neurol Sci. 2017 Jan 15;372:307-315. doi: 10.1016/j.jns.2016.11.071. Epub 2016 Dec 3.
citation: Woldeamanuel YW, Cowan RP. The impact of regular lifestyle behavior in migraine: a prevalence case-referent study. J Neurol. 2016 Apr;263(4):669-76. doi: 10.1007/s00415-016-8031-5. Epub 2016 Jan 25.