NCT07227194

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53,065

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2025

Completed
Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

November 9, 2025

Last Update Submit

November 11, 2025

Conditions

Migraine

Keywords

Migraine treatmentMachine learningNerivio app

Outcome Measures

Primary Outcomes (1)

  • Precision of the prediction model

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

    24 hours

Secondary Outcomes (5)

  • Specificity of the prediction model

    24 hours

  • Sensitivity of the prediction model

    24 hours

  • Accuracy of the prediction model

    24 hours

  • Area Under the Curve (AUC)

    24 hours

  • F1 score for the prediction model

    24 hours

Study Arms (1)

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.

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Theranica USA Inc

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Liron Rabany, PhD

    Theranica Bio-Electronics ltd

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2025

First Posted

November 12, 2025

Study Start

February 7, 2025

Primary Completion

August 1, 2025

Study Completion

August 20, 2025

Last Updated

November 12, 2025

Record last verified: 2025-11

Locations

US(1)