MigraineNCT07227194
Machine Learning Assessment of Next-Day Migraine Likelihood
An observational study of Migraine, run by Theranica at 1 site in United States.
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.
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 group | Role | What they receive |
|---|---|---|
| Migraine patients who used the Nerivio device app | Nerivio 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.
Precision of the prediction model
The percentage of migraine days correctly predicted, out of all predicted days.
Measured: 24 hours
Secondary outcomes (5)
Specificity of the prediction model
The percentage of non-migraine days correctly predicted, out of all the non-migraine days
Measured: 24 hours
Sensitivity of the prediction model
The percentage of migraine days correctly predicted, out of all the migraine days.
Measured: 24 hours
Accuracy of the prediction model
The percentage of days correctly predicted (migraine and non-migraine), out of all the predicted days
Measured: 24 hours
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
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.
- First posted12 Nov 2025
- Study start7 Feb 2025
- Primary completion1 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCG IRB
- Responsible party
- Sponsor
- Investigators
- Liron Rabany, PhD, Study director, Theranica Bio-Electronics ltd
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning Assessment Of Next-Day Migraine Likelihood Collected Via The Nerivio App
- ClinicalTrials.gov ID
- NCT07227194
- Acronym / sponsor ID
- RWE-011
- Conditions
- Migraine
- Keywords
- Migraine treatment, Machine learning, Nerivio app
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53,065 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Collaborators
- WCG IRB
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Migraine patients who used the Nerivio device app | – | –Nerivio 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Migraine patients that were prescribed and treated their migraine with the Nerivio device
Key inclusion criteria (2 listed)
- - Nerivio users age 8 and above.
- - Filled at least 2 daily diaries/ pre-treatment reports via the Nerivio app during the same month.
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Precision of the prediction model
Time frame: 24 hours
The percentage of migraine days correctly predicted, out of all predicted days.
5 secondary outcomes
Specificity of the prediction model
Time frame: 24 hours
Sensitivity of the prediction model
Time frame: 24 hours
Accuracy of the prediction model
Time frame: 24 hours
Area Under the Curve (AUC)
Time frame: 24 hours
F1 score for the prediction model
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liron Rabany, PhD study director
Theranica Bio-Electronics ltd
1 site in 1 country: see every site and its status.
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.