Chronic Migraines and Neurofdeeback Mindfulness

Chronic Migraine, Headache Clinical Trial

Official title:

Study Protocol for a Randomized Controlled Trial of Neurofeedback Mindfulness in Chronic Migraines

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06342219
• Other study ID #: 423629
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: University of Saskatchewan
• Contact: Faly Golshan, PhD Candidate
• Phone: 3062702765
• Email: faly.golshan[@]usask.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 135
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Migraine, Headache
• Headache
• Migraine Disorders

Intervention

Behavioral:
• Neurofeedback Mindfulness
The participants will use a portable EEG headband (MUSE) which is a noninvasive tool for collecting EEG data. They will receive real-time EEG data given an audio feedback while doing their daily mindfulness practice.
• Attention Task
The participants in this arm will use the portable EEG while listening to an audiobook. They will receive a summary of their brain activities after task completion on each day.

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine Disability	measured by Migraine Disability Assessment Scale (MIDAS)	8 weeks
Primary	Migraine Severity	measured by Headache Impact Test-short form (HIT-6)	8 weeks
Primary	Headache management self-efficacy	measured by Headache Management Self-Efficacy Scale	8 weeks
Primary	Dependence on medicine	measured by Severity of Dependence Scale (SDS)	8 weeks
Secondary	Anxiety	measured by BECK Anxiety Inventory (BAI)	8 weeks
Secondary	Depression	measured by The Center for Epidemiologic Studies Depression (CES-D)	8 weeks