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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06342219
Other study ID # 423629
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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