The Efficacy of Neurofeedback Mindfulness in Migraine Management

NCT06342232 | Completed DMC

• 2 other identifiers: BEH1986423629
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This longitudinal randomized controlled trial explored how long-term practice of neurofeedback mindfulness would be helpful for migraine management when compare dot a similar controlled intervention. All the participants went through assigned 10 minutes practices on a daily basis for 8 weeks. Behavioural reports and migraine characteristics were compared before and after the intervention.

Conditions

Migraine Headaches

Keywords

migraine; neurofeedback mindfulness; RCT

Outcome Measures

Primary Outcomes (3)

• Migraine Disability

  Based on MIDAS scale

  8 Weeks

• Migraine Severity

  Based on Hit-6 Scale

  8 Weeks

• Headache Management Self-efficacy

  Based on HMSE scale

  8 Weeks

Secondary Outcomes (2)

• Anxiety

  8 Weeks

• Depression

  8 Weeks

Study Arms (2)

Neurofeedback Mindfulness

EXPERIMENTAL

The participants received 8 weeks of intervention (10 min/day) including a neurofeedback mindfulness exercise via a portable EEG headband.

Behavioral: Neurofeedback mindfulness

Simple Attention Task

ACTIVE COMPARATOR

In the control group, the participants used the portable EEG headband for the same duration of intervention (8 weeks of practice, 10 min/day), but only listened to an audiobook without realtime access to their EEG recordings.

Behavioral: Simple attention controlled task

Interventions

Neurofeedback mindfulness BEHAVIORAL

The participants used a portable EEG headband to complete 10 minutes of neurofeedback mindfulness practice for 8 weeks. While being seated comfortably, they could modify their brains rates based on the audio neurofeedback they received.

Neurofeedback Mindfulness

Simple attention controlled task BEHAVIORAL

The controlled group of this project also received an intervention which included an audiobook. While wearing the headband, the controlled participants muted their neurofeedback sounds and only focused on an audiobook while remaining relaxed. A summary of their brain states was given to them when completing their practice every day.

Simple Attention Task

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age (over 18 years of age)
• a migraine diagnosis or having met the criteria for any type of migraine diagnosis based on ICHD-3 4. residing in Saskatoon or being able to receive the device from Saskatoon and the communities nearby
• having a smartphone and internet connection for accessing the MUSE app

You may not qualify if:

• Frequent background experience of meditation
• Comorbidity of Raynaud's syndrome or diabetes
• Current use of a preventative migraine treatment over 6 months

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5A2, Canada

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Marla Mickleborough

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: September 9, 2021
• Primary Completion: December 24, 2022
• Study Completion: March 1, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)