Determining the Utility of a Behavioral Intervention in Chronic Migraine

NCT05415020 | Recruiting

• 2 other identifiers: 24-004888K01NS124911
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Headache; Migraine Disorders; Chronic Migraine; Lifestyle Factors; Headache Disorders

Keywords

Migraine Disorders; Headache; Lifestyle

Outcome Measures

Primary Outcomes (2)

• Number of Interested Participants that are Enrolled

  Recruitment rate (Feasibility Outcome)

  12 weeks

• Acceptability

  Retention rate

  12 weeks

Secondary Outcomes (2)

• Mean change from baseline monthly migraine frequency

  12 weeks

• Migraine severity

  12 weeks

Other Outcomes (2)

• Headache self-efficacy

  12 weeks

• Levels of candidate biomarkers

  12 weeks

Study Arms (2)

Virtual Therapy Group

ACTIVE COMPARATOR

Behavioral: Lifestyle Behavior Protocol

Attention Placebo Group

SHAM COMPARATOR

Behavioral: Sham Behavior Protocol

Interventions

Lifestyle Behavior Protocol BEHAVIORAL

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

Virtual Therapy Group

Sham Behavior Protocol BEHAVIORAL

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

Attention Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 34357593 BACKGROUND

• 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.

  PMID: 32973989 BACKGROUND

• 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.

  PMID: 32071349 BACKGROUND

• 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.

  PMID: 30468246 BACKGROUND

• 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.

  PMID: 28017235 BACKGROUND

• 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.

  PMID: 26810728 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache; Headache Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Yohannes W. Woldeamanuel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Yohannes W. Woldeamanuel, MD

CONTACT

650-933-3560; Woldeamanuel.YohannesWoubishet@mayo.edu

Migraine Study

CONTACT

480-342-1385; azmigrainetrial@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 10, 2022
• Study Start: June 29, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 14, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 6 months after publication, for 5 years
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)