Study Protocol for a Randomized Controlled Trial of Neurofeedback Mindfulness in Chronic Migraines
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Saskatchewan
- Enrollment
- 135
- Locations
- 2
- Primary Endpoint
- Migraine Disability
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Marla Mickleborough
Dr. Marla Mickleborough
University of Saskatchewan