Study Protocol for a Randomized Controlled Trial on Neurofeedback Mindfulness and Its Efficacy on Migraine Management

This study was announced on PAWS platform from September 2020 until December 2021 available for students, professors, employees and alumni at the University of Saskatchewan. Before the participant recruitment, 218 volunteers provided their consent and filled out the initial survey to be evaluated based on the study's criteria. The eligibility criteria included age, an official diagnosis of migraine from a clinician or meeting criteria for a migraine diagnosis based on ICHD-3 (2018), residing in Saskatoon area, having frequent headaches at least once a month, and access to smartphone and internet connection. A priori exclusion criteria for this study were comorbidity of Raynaud's syndrome or diabetes, frequent use of a preventative migraine treatment, and background experience with meditation.

After applying inclusion and exclusion criteria, participants were randomly selected for the NM or the control group. An invitation letter was sent to 112 volunteers (NM=53, control=59); out of which 11 individuals (NM=4, control=7) refused to participate due to different reasons (e.g., COVID-19, difficulty with device delivery, starting preventative medication or unstable migraine attacks) or never responded to the invitation or the follow up emails.

101 participants started the RCT (NM=49, control=52) but after attritions, 68 participants completed their total practice days. 4 participants in the control group were excluded from data analysis due to missing questionnaires and therefore insufficient data for repeated measures analysis. Three participants were also excluded due to inconsistency in their data or ethical considerations. As a result, we ended up having 61 participants (meditation=34, control=27) with complete intervention and available data for analysis. The mean average age was similar between the NM (age M= 34.11, SD= 9.89) and control groups (age M= 31.51, SD= 10.20). In the NM group, there were 28 females (82.4%) and 6 males (17.6%) and in the control group, we had 21 females (77.8%) and 6 males (22.2%). At the end of the study, the NM group had filled out 148 diaries, and the control group provided 100 diaries about their headaches.

Data collection occurred between September 2021 to December 2022 dependent on the joining date of each participant.

The initial questionnaire of this study included 45 open-ended and multiple-choice questions (26 min to complete) and was used to distinguish the inclusion and exclusion criteria. Having given the consent, the volunteers provided demographic information about their headache characteristics, family history of migraine headaches, and background experience with meditation.