The general aim of this study will be to unveil that day-to-day variations in smartphone tappigraphy reflect dynamic changes in brain states that can be linked to the migraine attack cycle and triggers. We will use our self-developed and verified…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) To identify the tappigraphical patterns correlating with migraine attacks
as reported in the E-dairy and if tappigraphy can identify behavioural patterns
preceding (early) signs of upcoming migraine attacks.
Secondary outcome
(1) To correlate patient-reported triggers to migraine attacks based on the
E-diary;
(2) To correlate E-diary recorded data for sleep with tappigraphical patterns.
Background summary
The unpredictability of migraine attacks and the impact on daily life are major
concerns for migraine patients and may results in increased anxiety,
depression, and feelings of loss of control. Unpredictability is also an
obstacle in studying attack-related neurobehavioral alterations. Headache
diaries may provide insight into attack pattern and provoking trigger
mechanisms. However, self-reported registration will not offer continuous
information or the opportunity for detecting minimal behavioral alterations
preceding an attack. Smartphone-based monitoring of behavioral output
(tappigraphy) provides the ability for detailed monitoring of neurological
disease states. Furthermore, patient-reported triggers will be added to provide
information on known triggers such as sleep, menstruation, (relief of) stress
and diet. In the field of migraine, these tools are yet to be explored.
Study objective
The general aim of this study will be to unveil that day-to-day variations in
smartphone tappigraphy reflect dynamic changes in brain states that can be
linked to the migraine attack cycle and triggers. We will use our
self-developed and verified headache E-diary to identify triggers and detailed
characteristics of migraine attacks and link this to the tappigraphy
registrations from the TapCounter app. All data will be collected during a
period of 3 months in a group of migraine patients in order to phenotype the
course of a migraine attack, detect patient-specific trigger factors, and early
warning signs to eventually predict migraine attack occurrence.
Study design
Observational longitudinal cohort study
Study burden and risks
This is an observational study which does not include any intervention. As such
no direct risk is involved for the participants of this study. Data collected
using the TapCounter app will be encrypted in order to prevent any kind of
privacy violation.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
• At least be 18 years of age
• Fulfil ICHD-III criteria for migraine
• Patients must experience active migraine, which is defined for this study as
at least 1 attack per month.
• Willing to participate for at least 3 and for a maximum of 12 months
Exclusion criteria
• Unable or unwilling to use (digital) headache dairy and smartphone behaviour
app on a daily basis
• Diagnosed with other (chronic) neurological diseases such as Parkinson*s
disease, epilepsy etc. that may interfere with the results of this study.
• Chronic migraine as defined by the ICHD-3
• Severe depression and/or panic disorders and/or schizophrenia and/or
psychiatric disorders.
• Inability to differentiate between migraine and other headache diagnoses.
• Diagnosed with cluster headache or other TACs
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74778.058.21 |