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

NCT06180577 | Completed FDA Device

• 1 other identifier: RWE007
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine in Children

Keywords

Migraine; Nerivio; Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Limitations to migraine treatment at school

  1 year

• Types of migraine treatments during school

  1 year

Study Arms (1)

Adolescent Nerivio Users

Adolescent with migraine who used Nerivio at least once

Device: Nerivio

Interventions

Nerivio DEVICE

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

Adolescent Nerivio Users

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adolescents with migraine who used Nerivio at least once

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Theranica: lead

Study Sites (1)

Theranica USA Inc

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alit Stark Inbar, PhD

  Theranica Bio-Electronics Ltd

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: February 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 15, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)