Study Protocol for a Randomized Controlled Trial of Neurofeedback Mindfulness in Chronic Migraines
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Migraine, Headache
- Sponsor
- University of Saskatchewan
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Migraine Disability
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Marla Mickleborough
Dr. Marla Mickleborough
University of Saskatchewan
Eligibility Criteria
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
Outcomes
Primary Outcomes
Migraine Disability
Time Frame: 8 weeks
measured by Migraine Disability Assessment Scale (MIDAS)
Headache management self-efficacy
Time Frame: 8 weeks
measured by Headache Management Self-Efficacy Scale
Dependence on medicine
Time Frame: 8 weeks
measured by Severity of Dependence Scale (SDS)
Migraine Severity
Time Frame: 8 weeks
measured by Headache Impact Test-short form (HIT-6)
Secondary Outcomes
- Depression(8 weeks)
- Anxiety(8 weeks)