Nerivio Long-term Usage in Patients With Migraine

Completed

• Conditions: Migraine; Acute Treatment of Migraine

• Registration Number: NCT06738056
• Lead Sponsor: Theranica

Brief Summary

This is a Post-marketing study investigating the long-term safety, utilization, and efficacy of Remote Electrical Neuromodulation (REN) treatments during 3 consecutive years of using Nerivio device for in patients with migraine Safety will be assessed by the number and type of adverse events. Utilization will be measured by the number of monthly treatments. Efficacy will be evaluated as a change in headache pain severity and functional disability from baseline to 2 hours post-treatment in at least 50% of the treatments.

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 8 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 app 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 specifies 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 pain level (none, mild, moderate, severe), functional disability (None, Mild limitation, Moderate limitation, Severe limitation), 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, utilization, and efficacy in larger and more diverse populations 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 by analyzing data of patients who used the Nerivio device for consecutive 3 years: the following outcome will be assessed:

1. - Safety - all adverse events that were reported within the study's period

2. - Utilization - the number of Nerivio treatments per month

3. - Efficacy - pain relief, freedom from pain, improvement in functional disability, and return to normal function (no disability) at 2 hours posttreatment Together, these three objectives provide a comprehensive evaluation of longterm safety efficacy in a large real-world dataset

Study Timeline

• Study Start: 2024-12-01
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-17
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

1. • Users who treated migraine attacks consecutively for 3 years, with at least 9 months per year
2. • Users with at least one treatment recorded in each of the counted months during the 36 months.
3. • Users who had completed baseline and 2-hour post-treatment assessments for pain intensity and functional disability at least once in each of the counted months during the 36 months.

Exclusion Criteria

1 - When participants reported the use of concomitant acute migraine medications during treatments, these treatments were excluded from the analysis to isolate the effects of the Nerivio device.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device Related Adverse Events	3 Years	Incidence of device-related adverse events reported by subjects

Secondary Outcome Measures

Name	Time	Method
Consistent Headache Relief at 2 Hours Post-treatment	2 hours	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.; Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)
Consistent Freedom From Headache at 2 Hours Post-treatment	2 hours	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 headaches at treatment initiation to no headache 2 hours later
Consistent Functional Disability Relief at 2 Hours Post-treatment	2 hours	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.; Functional Disability level is reported using a 4-point Likert scale (0-No limitation, 1-Some limitation, 2-Moderate limitation, 3-Severe limitation)
Consistent Functional Disability disappearance at 2 Hours Post-treatment	2 hours	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.; Functional Disability level is reported using a 4-point Likert scale (0-No limitation, 1-Some limitation, 2-Moderate limitation, 3-Severe limitation)
Long Term Utilization of Nerivio	3 years	consistency of monthly usage of Nerivio device during 3 years period

Trial Locations

Locations (1)

Theranica Bio-Elewctronics Inc; 🇺🇸 Bridgewater, New Jersey, United States