Chronic Migraines and Neurofdeeback Mindfulness

Not Applicable

Not yet recruiting

• Conditions: Chronic Migraine, Headache
• Interventions: Behavioral: Neurofeedback Mindfulness; Behavioral: Attention Task

• Registration Number: NCT06342219
• Lead Sponsor: University of Saskatchewan

Brief Summary

As the second phase of our study on migraine headaches and neurofeedback mindfulness, we will explore how chronic migraineurs will benefit from a long term practice (8 weeks) of neurofeedback mindfulness compared to a similar attention group and a waitlisted group. This randomized controlled trial will also explore if migrianuers could decrease their dependence on medicine intake after completion of the study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Study Start: 2024-12
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• have a diagnosis of chronic migraine from a clinician or have met the criteria for a chronic migraine diagnosis based on ICHD-3
• reside in Saskatoon area
• have a smartphone and internet connection for accessing the MUSE app
• have no frequent background experience of meditation

Exclusion Criteria

• Comorbidity of Raynaud's syndrome or diabetes
• Current use of a preventative migraine treatment over 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
neurofeedback mindfulness	Neurofeedback Mindfulness	This group is asked to do 10 min/day practice of neurofeedback mindfulness for 8 weeks. They should sit comfortably in a quiet area and do one of ten beginner self-guided mindfulness sessions on mind-body scanning techniques from within the MUSE app. Each session includes a brief explanation for 2-3 minutes before the practice. Once the participants start their practices, they receive sounds for their real-time brain activities: thunderstorm for an active state, ocean waves for a neutral state, and birds chirping for a relaxed state. For each five seconds of consistent relaxed state, the participants are reinforced with points.
Attention Task	Attention Task	The participants in the controlled intervention group are assigned to have an attention routine in a relaxed position. They are required to sit comfortably and relax in a quiet area to put on their MUSE headband, set it up, and use the same practices on MUSE app but they will mute all the neurofeedback sounds and instructions. Instead, on their smartphone the participants will check their emails, the news, or their preferred social media platform for 10 minutes. Once the session is over, the participants receive the graphical feedback of their brain activities. The feedback includes a timeline indicating their brain states (active, or relaxed) during the 10-minute session.

Primary Outcome Measures

Name	Time	Method
Migraine Disability	8 weeks	measured by Migraine Disability Assessment Scale (MIDAS)
Migraine Severity	8 weeks	measured by Headache Impact Test-short form (HIT-6)
Dependence on medicine	8 weeks	measured by Severity of Dependence Scale (SDS)
Headache management self-efficacy	8 weeks	measured by Headache Management Self-Efficacy Scale

Secondary Outcome Measures

Name	Time	Method
Anxiety	8 weeks	measured by BECK Anxiety Inventory (BAI)
Depression	8 weeks	measured by The Center for Epidemiologic Studies Depression (CES-D)

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada