This is a prospective, observational study. The participant will be required to approve
      his/her participation in the study by completing the electronic consent form. Data collected
      within the first eight weeks (weeks 1-8) will be used to develop the prediction models
      (either personal or population/group models). The developed algorithm will be freezer and
      tested against the data collected during weeks 1-8 of a different cohort population

Observational Study to Assess Migraine Prediction Tool

Migraine

Migraine treatment may be acute (abortive) or preventive (prophylactic), with patients often
      requiring both. The objectives of acute treatment are to treat attacks early; to achieve
      quick pain relief; to minimize or eliminate adverse events; to restore function; to decrease
      recurrence and the need for rescue treatment; and to reduce medical resource use. Preventive
      treatment is aimed to lower the frequency, intensity, and duration of the attacks.

      In general, a prodrome is an early sign or symptom (or set of signs and symptoms) that often
      indicates the onset of a disease before more diagnostically specific signs and symptoms
      develop. Prodromal or premonitory symptoms occur in about 60% of those with migraines, with
      an onset that can range from two hours to two days before the start of pain or the aura.
      These symptoms may include a wide variety of phenomena including altered mood, irritability,
      depression or euphoria, fatigue, craving for certain food(s), stiff muscles (especially in
      the neck), constipation or diarrhea, and sensitivity to smells or noise. This may occur in
      those with either migraine with aura or migraine without aura. Neuroimaging indicates the
      limbic system and hypothalamus as the origin of prodromal symptoms in migraine.

      Robust prediction of migraine attacks could lead to pre-emptive treatment, provide patients
      with opportunities to plan for impending attacks, reduce interictal anxiety, and improve
      self-efficacy among other benefits.

      This study aims to develop and evaluate the effectiveness of a migraine prediction tool based
      on early prodromal (pre-migraine) symptoms, that may enhance the acute treatment of migraine

      Prior enrollment, Informed consent must be obtained from each participant before any
      protocol-related activities are performed. Participants will receive a daily notification
      (through an app notification) with a link to the daily questionnaire. The app may collect
      other data items, related to the specific location of every participant, such as weather, air
      quality, etc.

      The primary outcome measure is the presence of headache attack occurring over the 24-hour
      period recorded following a daily diary entry.

      During the development phase, 100% of the data will be used for developing and training the
      prediction model. Once the model will be ready, it will be "freezer" and used over a
      different cohort population to validate the prediction model. The AUC of the prediction model
      will be assessed to validate the accuracy (Specificity vs. Sensitivity) of the prediction
      model.

      The study will include the development of a general predictive model for the study
      population, with adjustments to individual participants, forecasting the probability of
      experiencing a headache and/or aura phase of a migraine attack during a particular interval.
      The outcome measure performance of this model using the Area Under the Curve (AUC) metric.
      The AUC model measures how often the algorithm predicts a higher probability for a migraine
      over non-migraine.

Daily questionnaire

Prospective, Observational Study to Assess Migraine Prediction Tool Based on Prodromal Symptoms and Additional Parameters

The primary endpoint will be the Predivio's prediction model sensitivity and specificity, presented by receiver operating characteristic (ROC) analysis using the Area Under the Curve (AUC) within the validation cohort population

Predivio's accuracy will be evaluated by the sensitivity and specificity, presented by the Area Under the Curve (AUC) within the validation cohort population

Predivio's percent of participants will be evaluated by the sensitivity and specificity of at least 80% within the validation cohort population

The training group will be used to develop the prediction model, based on their reported daily questionnaire. Participants in the training group will not be included in the Validation group

The validation group will be used only for validation (test) of the prediction model ("Naïve group"). Participants in the validation group could not be recruited from the training group

Observational Study to Assess Migraine Prediction Tool

About this trial

Study ID

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Type

Placebo

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Trial Timing

What is this trial about?

What are the participation requirements?

Locations

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