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

NCT ID: NCT06180577

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 332 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-05-15

Brief Summary

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.

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.

Conditions

Migraine in Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Adolescent Nerivio Users

Adolescent with migraine who used Nerivio at least once

Nerivio

Intervention Type: DEVICE

Nerivio is a prescribed Remote Electrical Neuromodulation (REN) device for treatment of migraine

Interventions

Nerivio

Nerivio is a prescribed Remote Electrical Neuromodulation (REN) device for treatment of migraine

Intervention Type: DEVICE

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theranica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alit Stark Inbar, PhD

Role: STUDY_DIRECTOR

Theranica Bio-Electronics Ltd

Locations

Theranica USA Inc

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

RWE007

Identifier Type: -

Identifier Source: org_study_id