Determining the Utility of a Behavioral Intervention in Chronic Migraine

NCT ID: NCT05415020

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2026-08-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine Headache Migraine Disorders Chronic Migraine Lifestyle Factors Headache Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtual Therapy Group

Group Type ACTIVE_COMPARATOR

Lifestyle Behavior Protocol

Intervention Type BEHAVIORAL

Virtual training on building a skillset to improve lifestyle behavior that reduces migraine attacks

Attention Placebo Group

Group Type SHAM_COMPARATOR

Sham Behavior Protocol

Intervention Type BEHAVIORAL

Virtual training on the disease of migraine and how migraine can progress to chronic migraine.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lifestyle Behavior Protocol

Virtual training on building a skillset to improve lifestyle behavior that reduces migraine attacks

Intervention Type BEHAVIORAL

Sham Behavior Protocol

Virtual training on the disease of migraine and how migraine can progress to chronic migraine.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yohannes Woubishet Woldeamanuel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr. Yohannes W. Woldeamanuel, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Phoenix, Arizona, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dr. Yohannes W. Woldeamanuel, MD

Role: CONTACT

650-933-3560

Migraine Study

Role: CONTACT

480-342-1385

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dakota Hohenwalter

Role: primary

480-574-1416

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34357593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32973989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32071349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30468246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28017235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26810728 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K01NS124911

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-004888

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nutrition for Migraine Prevention
NCT02012790 COMPLETED NA
Chronic Migraines and Neurofdeeback Mindfulness
NCT06342219 NOT_YET_RECRUITING NA
Migraine in Adolescents
NCT05654012 RECRUITING NA