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MigraineNCT07227194

Machine Learning Assessment of Next-Day Migraine Likelihood

An observational study of Migraine, run by Theranica at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Development of a machine learning (ML) algorithm for assessment of next-day migraine likelihood, drawing on self-reported migraine-related information, and geographic location, collected via the Nerivio app- a mobile application used for migraine treatment by the Remote Electrical Neuromodulation (REN) wearable device. Read more about this study

Who is it for?
Ages 8 years and older
Conditions the study is for
Migraine
How many people
53,065 participants
Where
1 siteUnited States
Study dates
7 Feb 2025to 20 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Migraine patients that were prescribed and treated their migraine with the Nerivio device

Who may be able to join

  • - Nerivio users age 8 and above.
  • - Filled at least 2 daily diaries/ pre-treatment reports via the Nerivio app during the same month.

Who cannot join

  • NA

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Theranica USA Inc

    Bridgewater, New Jersey, 08807

Other trials in United States

About this study

Official title: Machine Learning Assessment Of Next-Day Migraine Likelihood Collected Via The Nerivio App

Development of a machine learning (ML) algorithm for assessment of next-day migraine likelihood, drawing on self-reported migraine-related information, and geographic location, collected via the Nerivio app- a mobile application used for migraine treatment by the Remote Electrical Neuromodulation (REN) wearable device.

Read the detailed description

The analysis set includes patients with migraine who used Nerivio app for the reporting of migraine attacks and/or associated symptoms and/or migraine-related information.

Data collection is through the Nerivio app (Nerivio®). During app registration, patients consent to the collection of de-identified data for research purposes and provide demographic information. Participants can voluntarily report baseline characteristics such as treatment onset time relative to attack onset, headache pain, functional disability, and presence/absence of migraine-associated symptoms, as well as treatment outcomes 2-hours post-treatment. All data is stored on a HIPAA-compliant secure server.

The algorithm will be trained on user-level data. The dataset will be structured as a tabular matrix, where the columns represent risk-related features and the rows represent user-day observations. The feature set (X) serves as input variables, while the migraine occurrence label (Y) is the target outcome. The feature set (X) could be divided into four groups, according to the data source:

Demographic data - age and sex were self-reported via the app upon registration. The user's country is identified based on IP address.

Questionnaire data - features which are the patient's answers to either the daily diary questionnaire or a pre-treatment questionnaire. These include headache severity, functional disability, medication intake, aura, pain duration, and prodromal symptoms. Data on prodromal symptoms is collected via a multiple-choice question with 14 pre-defined answers.

Weather data - environmental features that are based on users' geographic location. These include barometric pressure, temperature, heat index, UV index, wind, humidity, and precipitation.

Calculated features - features that are calculated based on the aforementioned collected data. These include averages, frequencies, number of consecutive days, etc'.

Label (Y) Definition - The target variable (Y) will be defined using daily diary entries and pre-treatment questionnaires. The "next-day migraine" field served as the target outcome. A value of 1 (migraine day) will be assigned if a migraine was reported on the subsequent calendar day; a value of 0 (non-migraine day) will be assigned if no migraine was reported. Missing values were kept as null to capture potential information inherent in their non-random occurrence.

A day is classified as a migraine day (Y = 1) if both of the following conditions were met: A) Headache level was reported as mild, moderate, or severe in the diary or pre-treatment questionnaire. B) At least one additional migraine indicator was present: intake of migraine-related medication, or report of photophobia, phonophobia, nausea and/or vomiting, or aura in the diary or pre-treatment questionnaire.

The following standard ML outcome measures were used to evaluate model performance:

Precision- the percentage of migraine days correctly predicted, out of all predicted days.

Accuracy- the percentage of days correctly predicted (migraine and non-migraine), out of all the predicted days.

Sensitivity (also termed recall rate)- the percentage of migraine days correctly predicted, out of all the migraine days.

Specificity- the percentage of non-migraine days correctly predicted, out of all the non-migraine days.

Area Under the Curve (AUC)- the probability that the model ranks a migraine day higher than a non-migraine day, based on predicted risk scores (summarizing the model's ability to distinguish between migraine and non-migraine days across all classification thresholds).

F1 score- the balance between correctly predicted migraine days and avoiding wrongly-predicted migraine days, combining sensitivity and precision in one measure.

Conditions
Migraine
Keywords
Migraine treatment, Machine learning, Nerivio app
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07227194
Study groupRoleWhat they receive
Migraine patients who used the Nerivio device appNerivio users age 8 and above, who had filled at least 2 daily diaries or pre-treatment reports via the Nerivio app during the same month.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Precision of the prediction model

    The percentage of migraine days correctly predicted, out of all predicted days.

    Measured: 24 hours

Secondary outcomes (5)
  1. Specificity of the prediction model

    The percentage of non-migraine days correctly predicted, out of all the non-migraine days

    Measured: 24 hours

  2. Sensitivity of the prediction model

    The percentage of migraine days correctly predicted, out of all the migraine days.

    Measured: 24 hours

  3. Accuracy of the prediction model

    The percentage of days correctly predicted (migraine and non-migraine), out of all the predicted days

    Measured: 24 hours

  4. Area Under the Curve (AUC)

    The probability that the model ranks a migraine day higher than a non-migraine day, based on predicted risk scores (summarizing the model's ability to distinguish between migraine and non-migraine days across all classification thresholds).

    Measured: 24 hours

  5. F1 score for the prediction model

    The balance between correctly predicted migraine days and avoiding wrongly-predicted migraine days, combining sensitivity and precision in one measure.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2025
  2. Study start7 Feb 2025
  3. Primary completion1 Aug 2025
  4. Study completion20 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
53,065 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07227194
Sponsor's protocol ID
RWE-011
Status last verified
Nov 2025
First submitted
9 Nov 2025
Last updated
12 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine, run by Theranica at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Precision of the prediction model (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.

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