Determining the Utility of a Behavioral Intervention in Chronic Migraine

Migraine Clinical Trial

— RLB  

Official title:

Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415020
• Other study ID #: 61027
• Secondary ID: K01NS124911
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: February 3, 2025

Study information

• Verified date: September 2022
• Source: Stanford University
• Contact: Dr. Yohannes Woldeamanuel, MD
• Phone: 650-721-2830
• Email: ywoldeam[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 3, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Migraine
• Disease
• Headache
• Headache Disorders
• Lifestyle Factors
• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Lifestyle Behavior Protocol
Virtual training on building a skillset to improve lifestyle behavior that reduces migraine attacks
• Sham Behavior Protocol
Virtual training on the disease of migraine and how migraine can progress to chronic migraine.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 weeks
Other	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)	12 weeks
Primary	Feasibility	Recruitment rate	12 weeks
Primary	Acceptability	Retention rate	12 weeks
Secondary	Mean change from baseline monthly migraine frequency	Change in the mean of monthly migraine frequency	12 weeks
Secondary	Migraine severity	severity of migraine attacks rated from 0 to 10	12 weeks