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Neuromodulation during the prodrome to prevent disabling migraine attacks in children and adolescents – a pilot randomized controlled trial

Projet en cours

Project Overview

One in ten youth have migraine, a female-dominant disease with disabling attacks of moderate-to-severe headache. Current treatment plans are not very effective and occur after the pain starts, even though symptoms and changes in the brain appear earlier (known as the prodrome phase). A clinical trial involving adults with migraine showed that a pill-based treatment taken during the prodrome may prevent the pain from migraine before it starts. It is unclear if treatment during the prodrome would help children and adolescents with migraine, though pill-based treatments are not ideal for prodromal treatment in youth because of costs, unknown efficacy, and side effects. When we asked youth and parents about their preferences for migraine treatment, we found that most would rather use a device when pills are not practical or effective. Specifically, youth are interested in remote electrical neuromodulation (REN). REN devices are worn on the upper arm and gently deliver electrical signals to pain nerves, leading them to send signals to an area of the brain that can reduce incoming migraine pain. REN has been shown to be safe and effective during the pain phase for youth with migraine, but has never been studied for prodromal treatment. We will study if using REN during the prodrome can prevent migraine pain in children and adolescents. This will be a pilot clinical trial, where we will test the feasibility of this approach in a sample of 30 children and adolescents with migraine, aged 8-18 years, using a study design modeled after the adult clinical trial, but adapted to the needs and preferences of children and adolescents with migraine. The results of this research could lead to a paradigm shift in how migraine is treated in children and adolescents and enable youth to self-manage their disease in an innovative, patient-centered, and safe manner.

Partners & Donors

Azrieli Foundation