Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06342232 |
| Other study ID # |
BEH1986 |
| Secondary ID |
423629 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 9, 2021 |
| Est. completion date |
March 1, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
University of Saskatchewan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 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.
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 8:00 p.m. 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 35.84% in the NM group and 54.23% in the control group; this made the total rate of
attrition up to 39.60%. 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).
