A Survey Study to Assess the Accessibility of the Nerivio Device at School

A Retrospective Survey Study to Assess the Accessibility, Preference, and Frequency of Adolescents Using Nerivio in School Setting

This is a retrospective survey-study to assess the accessibility, preference, and frequency of adolescents using Nerivio by itself, in combination with pharmacological medications, or not at all, in the school setting. The study population is prescribed Nerivio users, under the age of 18 years old, who have used the Nerivio device at least once. The study will be conducted electronically, and will include eligibility questions, an electronic informed consent form signed by the parent/legal guardian (e-ICF), an assent form signed by the adolescent patient (e-Assent), and an e-survey relating to the management of headaches due to migraine attacks. Participants will be recruited from Nerivio's userbase and will be compensated for their participation.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine in Children
• Intervention / Treatment: Device: Nerivio

Detailed Description

This is a retrospective survey-study to assess the accessibility, preference, and frequency of adolescents using Nerivio by itself, in combination with pharmacological medications, or not at all, in the school setting. The study population is prescribed Nerivio users, under the age of 18 years old, who have used the Nerivio device at least once.

Study group: Participants will be recruited from Nerivio's user database. An invitation message will be sent via emails and/or in-app notifications to Nerivio users who are (1) under the age of 18 years old, and (2) treated with Nerivio at least once. Adolescents who meet these criteria will be invited to answer a screening questionnaire verifying eligibility.

Adolescents who are found eligible will be offered the opportunity to participate in the study. If they are willing, they will first be directed to an Informed Consent Form (e-ICF) to be signed by the participant's parent/legal guardian. A copy of the completed form will be automatically sent to the parent/legal guardian upon completion. If the parent/legal guardian consents via the e-ICF to his/her child's participation, an electronic assent form will follow and must be signed by the adolescent patient. A copy of the assent form will be automatically sent to the parents and the adolescent patient. Once both electronic consent forms are signed, the adolescent patient will be enrolled in the study and will be directed to the study survey.

Primary outcome measures:

Percent of adolescents' who prefer treating headaches due to migraine when they are at school with Nerivio alone, relative to other options (combination, pharmaceutical, not treating while in school).

Secondary outcome measures:

1. - Distribution of barriers to adolescents who report the necessity to treat their headaches due to migraine while at school, including the need to leave class for treatment, lack of availability of treatments while at school, and time delay to treat headaches.
2. - Distribution of treatments used by adolescents at school to treat migraine headaches prior to being prescribed Nerivio (specific pharmaceutical agents, or not treating at all) reflecting convergence to using Nerivio at school.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Dagan Harris, PhD; Phone Number: +972-73-3703649; Email: daganh@theranica.com
• Study Contact Backup: Name: Alit Stark-Inbar, PhD; Phone Number: +972-73-3703649; Email: Alitsi@theranica.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adolescents with migraine who used Nerivio at least once

Description

Inclusion Criteria:

• Age ≤18 years old at registration to the Nerivio app
• Treated with Nerivio at least once (≥30 minutes/treatment).
• Attended elementary, middle, junior high, or high school, while first prescribed Nerivio
• Must obtain parent/legal guardian consent form prior to signing the assent form by the adolescent and engaging in study survey.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adolescent Nerivio Users; Adolescent with migraine who used Nerivio at least once	Device: Nerivio; Nerivio is a prescribed Remote Electrical Neuromodulation (REN) device for treatment of migraine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nerivio usage at school	Percent of adolescents who prefer treating headaches due to migraine when they are at school with Nerivio alone, relative to other options (combination, pharmaceutical, not treating while in school).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limitations to migraine treatment at school	Distribution of barriers to adolescents who report the necessity to treat their headaches due to migraine while at school, including need to leave class for treatment, lack of availability of treatments while at school, time delay to treat headaches.	1 year
Types of migraine treatments during school	Distribution of treatments used by adolescents at school to treat migraine headaches prior to being prescribed Nerivio (specific pharmaceutical agents, or not treating at all) reflecting convergence to using Nerivio at school.	1 year

Collaborators and Investigators

• Sponsor: Theranica
• Investigators: Study Director: Alit Stark Inbar, PhD, Theranica Bio-Electronics Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2023
• Primary Completion (Estimated): January 15, 2024
• Study Completion (Estimated): January 20, 2024

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Migraine; Headache; Nerivio
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: RWE007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No