Observational Study to Assess Migraine Prediction Tool

NCT05523310 | Suspended

• 1 other identifier: TCH010
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Migraine

Keywords

Migraine prediction; Migraine prodrome; Migraine prevention

Outcome Measures

Primary Outcomes (1)

• Validation of an effective algorithm and software to predict migraine attacks.

  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

  Predication period of 24 hours prior headache

Secondary Outcomes (2)

• Predivio accuracy

  Predication period of 24 hours prior headache

• Predivio's percent of participants for whom the sensitivity and specificity are at least 80%.

  Predication period of 24 hours prior headache

Other Outcomes (2)

• Difference in prescribed medications usage

  8 weeks

• Health economics analysis

  8 weeks

Study Arms (2)

Training group

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

Other: Daily questionnaire

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

Other: Daily questionnaire

Interventions

Daily questionnaire OTHER

All patients will be asked to complete a daily questionnaire regarding their migraine, medications, and prodromal symptoms during that day

Training group; Validation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population consists of migraineurs who have already used Nerivio and its mobile application prior to joining the study and those who have not, with a target ratio of 50:50 (and up to 30:70 or 70:30) between these two subject types

You may qualify if:

• Subject age 18-75 years.
• Subject has migraine diagnosis for over 6 months prior to enrolling to the study.
• Subject has 4-24 headache days per month.
• Subject has a Nerivio user account, or willing to create a Nerivio user account to participate in the study.
• Subject is willing to sign an Informed Consent Form.

Sponsors & Collaborators

• Theranica: lead

Study Sites (3)

Westport Headache Institute

Westport, Connecticut, 06880, United States

Location

Headache Neurology Research Institute

Ridgeland, Mississippi, 39157, United States

Location

Nuvance Health Vassar Medical Center

Poughkeepsie, New York, 12601, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start (Estimated): January 1, 2030
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): November 15, 2030
• Last Updated: November 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)