Health TrialsbyHealthPanel

Chronic Migraines and Neurofdeeback Mindfulness

ConditionChronic Migraine, Headache
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Saskatchewan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Comorbidity of Raynaud's syndrome or diabetes

Current use of a preventative migraine treatment over 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neurofeedback Mindfulness

    Behavioral

    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

    Behavioral

    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.

Treatment groups

135 Participants
are divided into 3 treatment groups
Group A: neurofeedback mindfulnessExperimental treatment 1 intervention
Group B: Attention TaskActive comparator 1 intervention
Group C: Waitlisted GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Migraine Disability

measured by Migraine Disability Assessment Scale (MIDAS)

Time frame
8 weeks
2

Migraine Severity

measured by Headache Impact Test-short form (HIT-6)

Time frame
8 weeks
3

Headache management self-efficacy

measured by Headache Management Self-Efficacy Scale

Time frame
8 weeks
4

Dependence on medicine

measured by Severity of Dependence Scale (SDS)

Time frame
8 weeks

Secondary outcomes

1

Anxiety

measured by BECK Anxiety Inventory (BAI)

Time frame
8 weeks
2

Depression

measured by The Center for Epidemiologic Studies Depression (CES-D)

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Saskatchewan

Lead sponsor

Saskatchewan Health Research Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: