NCT05769322

Real World Data Analysis: Impact of High-Frequency REN Treatments As Migraine Preventive Therapy in Adolescence

Remote Electrical Neuromodulation (REN) Wearable Device for Adolescents with Migraine: Real World Study of High-Frequency Users Suggest Preventive Effects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 83 (actual)
• Sponsor: Theranica · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a post-marketing study investigating the safety and efficacy of the REN device (Nerivio by Theranica, ISRAEL) in adolescents with migraine. The data analysis will test the ability of Frequent use of REN for the acute treatment of migraine to reduce the number of monthly migraine days in subsequent months, suggesting potential preventive benefits.

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 of 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 app that is downloaded to the user's phone prior first use of the Nerivio device. As part of the sign-up process to the Nerivio app, all patients accept the terms of use which specify that providing personal information is done by 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 pain level (none, mild, moderate, severe), functional disability (No limitation, Some limitation, Moderate limitation, Severe limitation), and an indication of which medications, if any, were taken within that 2-hour time window. This post-marketing RWE study investigates the potential of high usage of Nerivio for the acute treatment of migraine on migraine prevention, using the following outcomes: 1. \- reduction in mean monthly migraine treatment days (MMTD), 2. \- acute treatment efficacy measured 2 h post-treatment 3. \- improve in functional disability 4. \- Device safety Together, these objectives may provide a comprehensive evaluation of the impact of the high usage of Nerivio for acute treatment as a migraine preventive tool in the migraine adolescent population.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	Nerivio	Remote electrical neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-04-15
• Completion: 2023-05-01
• First posted: 2023-03-15
• Last updated: 2024-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study