Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342232
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Brief Title:
The Efficacy of Neurofeedback Mindfulness in Migraine Management
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
Study Protocol for a Randomized Controlled Trial on Neurofeedback Mindfulness and Its Efficacy on Migraine Management
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 studys 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 Raynauds 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 NM53 control59 out of which 11 individuals NM4 control7 refused to participate due to different reasons eg 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 NM49 control52 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 meditation34 control27 with complete intervention and available data for analysis The mean average age was similar between the NM age M 3411 SD 989 and control groups age M 3151 SD 1020 In the NM group there were 28 females 824 and 6 males 176 and in the control group we had 21 females 778 and 6 males 222 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
After checking the availability criteria the invited participants received a coded email information with a description of their practice as well a copy of their consent form and contact information of a researcher in charge for device delivery Before device delivery the researchers checked COVID-19 self-screening measures
A zoom meeting was scheduled estimated for 30-60 minutes after the participants would receive the device In the initial meeting the participants were introduced to focused listening and mind wandering states they were suggested to block mind wandering during the sessions by attending to the audiobook carefully Followed by the practice session the participants would receive the same feedback of brain activities as shared by the NM group The feedback included a timeline indicating their brain states active or relaxed during the practice as well as reinforced consistent relaxed states In this way the control group task was identical to the NM group except that they listened to an audiobook instead of doing the NM intervention For the whole duration of data collection September 2021-December 2022 the sessions were monitored daily via MUSE Connect and were transcribed on an Excel file with information about numbers and reasons for missing days
During the online session participants received a brief introduction to the study goals and the participants assigned task and they were instructed on how to use the headband and the MUSE app to complete their given exercises both in the NM and control group Participants were required to complete the pre-intervention questionnaire on the day of the initial meeting After the initial meeting they received daily reminders scheduled for 800 pm by a researcher They were required to respond to the researcher by sending 1 for a complete session Participants received a manual reply to keep them more engaged in the intervention All the participants practices were monitored daily via MUSE Connect Information was collected about the duration of their practice as well as the percentage of their relaxed or active states In case of a pause in daily practices for more than three sessions the researcher would send a follow up email asking for the reason of the pause in the intervention In the event of having issues with the device a EEG headband replacement was scheduled to be delivered to participants upon their availability Additionally the participants received weekly reminder text messages for headache diary questionnaires that were accessible via a SurveyMonkey link on their cellphones Time to complete the diaries was estimated about 9 minutes and the diaries included 24 multiple choices about subjects recent headache experience
On Week 8 of the study the participants were given the post-intervention questionnaires to complete In case of not completing the questionnaires reminder emails were sent for 1 week
Since this study was demanding and expected high amount of commitment for a long period of time the participants collaboration was appreciated by allowing them to keep their MUSE EEG headband at the end of the study after completion of the data The participants who withdrew before completion were also allowed to keep their device
Based on the rate of withdrawals and commitment to fill out the questionnaires the attrition rate was 3584 in the NM group and 5423 in the control group this made the total rate of attrition up to 3960 Since the rate of adherence to completing questionnaires and staying on task was different in the two groups regardless of equal and balanced task requirements this information is used as an indication of the interventions feasibility and participants adherence to the tasks
We utilized five measurements administered to participants before and after the study On average completing the five questionnaires was estimated to take about 13 minutes These measurements collected information about migraine disability MIDAS headache severity HIT-6 headache management self-efficacy HMSE anxiety BAI and depression CES-D
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 NM53 control59 out of which 11 individuals NM4 control7 refused to participate due to different reasons eg 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 NM49 control52 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 meditation34 control27 with complete intervention and available data for analysis The mean average age was similar between the NM age M 3411 SD 989 and control groups age M 3151 SD 1020 In the NM group there were 28 females 824 and 6 males 176 and in the control group we had 21 females 778 and 6 males 222 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
After checking the availability criteria the invited participants received a coded email information with a description of their practice as well a copy of their consent form and contact information of a researcher in charge for device delivery Before device delivery the researchers checked COVID-19 self-screening measures
A zoom meeting was scheduled estimated for 30-60 minutes after the participants would receive the device In the initial meeting the participants were introduced to focused listening and mind wandering states they were suggested to block mind wandering during the sessions by attending to the audiobook carefully Followed by the practice session the participants would receive the same feedback of brain activities as shared by the NM group The feedback included a timeline indicating their brain states active or relaxed during the practice as well as reinforced consistent relaxed states In this way the control group task was identical to the NM group except that they listened to an audiobook instead of doing the NM intervention For the whole duration of data collection September 2021-December 2022 the sessions were monitored daily via MUSE Connect and were transcribed on an Excel file with information about numbers and reasons for missing days
During the online session participants received a brief introduction to the study goals and the participants assigned task and they were instructed on how to use the headband and the MUSE app to complete their given exercises both in the NM and control group Participants were required to complete the pre-intervention questionnaire on the day of the initial meeting After the initial meeting they received daily reminders scheduled for 800 pm by a researcher They were required to respond to the researcher by sending 1 for a complete session Participants received a manual reply to keep them more engaged in the intervention All the participants practices were monitored daily via MUSE Connect Information was collected about the duration of their practice as well as the percentage of their relaxed or active states In case of a pause in daily practices for more than three sessions the researcher would send a follow up email asking for the reason of the pause in the intervention In the event of having issues with the device a EEG headband replacement was scheduled to be delivered to participants upon their availability Additionally the participants received weekly reminder text messages for headache diary questionnaires that were accessible via a SurveyMonkey link on their cellphones Time to complete the diaries was estimated about 9 minutes and the diaries included 24 multiple choices about subjects recent headache experience
On Week 8 of the study the participants were given the post-intervention questionnaires to complete In case of not completing the questionnaires reminder emails were sent for 1 week
Since this study was demanding and expected high amount of commitment for a long period of time the participants collaboration was appreciated by allowing them to keep their MUSE EEG headband at the end of the study after completion of the data The participants who withdrew before completion were also allowed to keep their device
Based on the rate of withdrawals and commitment to fill out the questionnaires the attrition rate was 3584 in the NM group and 5423 in the control group this made the total rate of attrition up to 3960 Since the rate of adherence to completing questionnaires and staying on task was different in the two groups regardless of equal and balanced task requirements this information is used as an indication of the interventions feasibility and participants adherence to the tasks
We utilized five measurements administered to participants before and after the study On average completing the five questionnaires was estimated to take about 13 minutes These measurements collected information about migraine disability MIDAS headache severity HIT-6 headache management self-efficacy HMSE anxiety BAI and depression CES-D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 423629 | OTHER_GRANT | Saskatchewan Health Research Foundation | None |