Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)

Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, prescribed, wearable device, FDA-cleared for acute and/or preventive treatment of migraine with or without aura in patients 12 years or older. Multiple studies have shown that REN has high safety, tolerability, and efficacy in adults and adolescents. This study aims to evaluate REN's real-world safety and efficacy in pre-adolescents, 9-11 years old.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Device: Nerivio

Detailed Description

The REN device (Nerivio by Theranica, ISRAEL) is a neuromodulation device approved by the FDA for acute and/or preventive treatment of migraine in patients 12 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers using a modulated, symmetrical, biphasic, square pulse with a pulse width of 400 μs, modulated frequency of 100-120 Hz, and up to 40 mA output current which the patient can adjust.

The REN device is operated by a designated smartphone application that is downloaded to the user's phone prior first use of the Nerivio device. As part of the sign-up process for the Nerivio app, all patients accept the terms of use which specify that providing personal information is done on their own free will and that their de-identified data may be used for research purposes. Users are not obligated to provide personal information and could treat without providing any feedback. The app includes a secure, personal migraine diary, which enables patients to record and track their migraines and other headaches. At the beginning of each treatment, and again 2 hours after the start of treatment, patients are prompted to record their symptoms, including the presence or absence of aura, pain level (none, mild, moderate, severe), functional disability (none, mild limitation, moderate limitation, severe limitation), presence of associated symptoms (photophobia, phonophobia, and nausea), and an indication of which medications, if any, were taken within that 2-hour time window.

Post-marketing surveillance is designed to assess the safety and efficacy of REN in larger and more diverse populations than in clinical trials and in various real-world environments and situations. As a digital therapeutic device (i.e., electroceutical), the REN device enables prospective collection of electronic patient-reported outcomes in real-world clinical practice.

This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment in pre-adolescence migraine patients who used the Nerivio device. The following outcomes will be assessed:

1. - Safety - all adverse events that were reported during the study's period
2. - Efficacy - pain relief, freedom from pain, improvement in functional disability, and improvement in migraine-associated symptoms following the treatment

Together, these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine in this target population.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Israel
  • Netanya, Israel, 4250438
    • Theranica Bio-Electronics Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Pre-adolescence (age 9-11) who suffers from migraine and are using the Nerivio device for acute treatment of migraine.

Description

Inclusion Criteria:

• Subject age is between 9 to 11 (included) at the date of the REN treatment
• Subject used the Nerivio device at least once

Exclusion Criteria:

• Treatments shorter than 30 minutes

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-adolescence with migraine; Patients at the age of 9-11with migraines who used the Nerivio device at least once	Device: Nerivio; Neriio is a remote electrical neuromodulation (REN) device for the treatment of migraine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Related Adverse Events	Incidence of device-related adverse events reported by subjects	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consistent Headache Relief at 2 Hours Post-treatment	The proportion of subjects reporting headache relief at 2 hours post-treatment in at least 50% of all their treatments. Headache relief is defined as an improvement from severe or moderate pain to mild or no pain.	2 hours
Consistent Freedom From Headache at 2 Hours Post-treatment	The proportion of subjects reporting freedom from headache at 2 hours post-treatment in at least 50% of all their treatments. Pain freedom is defined as the disappearance of headache from severe, moderate, or mild headache at treatment initiation to no headache 2 hours later	2 hours
Associated Symptoms Freedom	The proportion of subjects reporting the presence of each of the migraine-associated symptoms (photophobia, phonophobia, nausea) at the beginning of treatment and reported their absence in at least 50% of their attacks.	2 hours
Consistent Functional Disability Relief at 2 Hours Post-treatment	The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported improvement of at least one level of Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.	2 hours
Consistent Functional Disability disappearance at 2 Hours Post-treatment	The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported no Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.	2 hours

Collaborators and Investigators

• Sponsor: Theranica
• Investigators: Principal Investigator: Alit Stark Inbar,, PhD, Theranica

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): October 20, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: November 11, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Estimated): November 20, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Adolescence; REN; 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: RWE009

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: Yes
• product manufactured in and exported from the U.S.: No