NCT06023953

Migraine With and Without Aura Characteristics and Response to Remote Electrical Neuromodulation (REN) Treatment

Comparison of Migraine With and Without Aura in a Large Cohort: Characteristics and Response to Remote Electrical Neuromodulation (REN) Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31,715 (actual)
• Sponsor: Theranica · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

This is a Post-marketing, real-world evidence study investigating the safety and efficacy of the acute treatment of migraine with a Remote Electrical Neuromodulation (REN) device (Nerivio) in migraine patients with and without aura, as well as characterizing demographic and attack characteristic differences between migraine patients with and without aura. Safety will be assessed by the number and type of device-related adverse events. Efficacy will be evaluated as a change in headache pain severity from baseline to 2 hours post-treatment. Disease characteristics will look into demographic and attack differences between patients with and without aura.

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. 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 secured, 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. This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment in patients with and without aura by analyzing data from patients who used the Nerivio device. The following outcomes will be assessed: 1. Migraine clinical characteristics - Headache pain severity, functional disability and presence of associated symptoms at treatment baseline. 2. Consistent efficacy - Pain relief, freedom from pain, functional disability relief, return to normal function (no disability) and freedom from associated symptoms at 2 hours post-treatment relative to baseline in at least 50% of the treatments. 3. Safety - Rate of serious adverse events, and device-related adverse events in the study's period. Together, these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine with or without aura.

Conditions

• Migraine With Aura
• Migraine Without Aura

Interventions

Type	Name	Description
DEVICE	Nerivio device	REN treatment with Nerivio device

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-09-30
• Completion: 2024-12-01
• First posted: 2023-09-05
• Last updated: 2025-08-15

Locations

1 site across 1 country: Israel