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

Last updated: January 26, 2024
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Oral Facial Pain

Migraine (Adult)

Treatment

Migraine Behavioral Treatment

Clinical Study ID

NCT06170281
70767
K01NS124911
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • secondary headache disorders
  • children younger than 18 years old

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Migraine Behavioral Treatment
Phase:
Study Start date:
December 15, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Stanford University

    Stanford, California 94305
    United States

    Active - Recruiting

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