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Chronic Migraines and Neurofdeeback Mindfulness

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06342219
Enrollment
135
Registered
2024-04-02
Start date
2024-12-31
Completion date
2026-06-30
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Migraine, Headache

Keywords

neurofeedback mindfulness, headache management self-efficacy, chronic migraines, dependence behaviours, migraine severity

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.

Interventions

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.

BEHAVIORALAttention 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.

Sponsors

Saskatchewan Health Research Foundation
CollaboratorOTHER
University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Migraine Disability8 weeksmeasured by Migraine Disability Assessment Scale (MIDAS)
Migraine Severity8 weeksmeasured by Headache Impact Test-short form (HIT-6)
Headache management self-efficacy8 weeksmeasured by Headache Management Self-Efficacy Scale
Dependence on medicine8 weeksmeasured by Severity of Dependence Scale (SDS)

Secondary

MeasureTime frameDescription
Anxiety8 weeksmeasured by BECK Anxiety Inventory (BAI)
Depression8 weeksmeasured by The Center for Epidemiologic Studies Depression (CES-D)

Countries

Canada

Contacts

Primary ContactFaly Golshan, PhD Candidate
faly.golshan@usask.ca3062702765
Backup ContactMarla Mickleborough, PhD
marla.mick@usask.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026