Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial

Migraine Clinical Trial

— SMARTMig  

Official title:

A Feasibility Clinical Trial Assessing Patient Preference, Optimum Combinations and Sequences of a Multicomponent, Virtually-Delivered Migraine Behavioral Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170281
• Other study ID #: 70767
• Secondary ID: K01NS124911
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: Yohannes W Woldeamanuel, MD
• Phone: +1-650-304-6402
• Email: ywoldeam[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will unpack the behavioral intervention for migraine and determine the optimum combinations. In addition, the study will test preference and self-selection effects during the trial.

Description:

After a 4-week screening period, eligible candidates (14 headache days in 4 week period, with 8 days being migraine) will be randomized into 2 arms -

• Choice Arm: allowed to choose from a menu of migraine behavioral treatment options

• Random: randomized to migraine behavioral treatment options.

After 6 weeks, all participants will be assessed for their migraine frequency. Patients will be considered Responders if the migraine frequency is reduced to 50%. The Non-responders (NR) of the Choice Arm will be again given a chance to pick any of the 3 arms. The NR of the randomized arm will be randomized to any of the 3 arms. The responders will continue for 6 more weeks in their original arms. By the end of the 12 weeks, all participants will complete the study, and migraine frequency will be compared between the different groups. All behavioral interventions will be delivered virtually.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• 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:

• secondary headache disorders

• children younger than 18 years old

Related Conditions & MeSH terms

• Chronic Migraine
• Headache
• Headache Disorders
• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities

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 (3)

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. 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, 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
Primary	Feasibility in terms of recruitment and adherence rates	recruitment rate, adherence rate	12 weeks
Secondary	Migraine Frequency	migraine day frequency	at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Secondary	Headache Self-efficacy	headache self-efficacy measured using validated headache self-efficacy questionnaire	at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Secondary	Migraine Intensity	migraine intensity, self-reported	at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization