Wearable neurostimulation device for childhood migraine headache treatment: A safety study
Many have experienced the troublesome and debilitating effects of migraine, including severe head pain, vomiting, light and sound sensitivity. Migraine can disrupt numerous facets of a child's life, causing both school and social absences. Unfortunately, treatment-resistant migraine in children is difficult to manage, often involving medications, behavioral strategies, and sometimes injection therapy. Besides the financial burden on patients, some of these therapies also have unintended side effects. This can include ulcers and kidney damage as side effects from strong painkillers such as opioids and anti-inflammatories. Developing alternative methods for acute treatment of migraines may be advantageous to improving pain outcomes and minimizing disability. One such alternative therapy is CEFALY, a wearable medical device that provides electrical impulses to nerves in the forehead involved in headache generation. CEFALY is government-approved in adult populations and found to significantly reduce pain during migraine attacks. The advantages of CEFALY include precise targeting to the site of pain (i.e., forehead), reusability, and the option to administer self-treatment in the comfort of home. The efficacy of CEFALY for pediatric use has thus far been untested, preventing a large population from accessing this potentially valuable therapy. This study aims to explore the use of CEFALY in 50 adolescents experiencing migraine attacks. Symptom reduction will be measured using a self-reported visual pain scale before, one hour, and two hours after treatment with the device. This study will be conducted remotely, with patients given a personal CEFALY device and educated on its use by an e-health appointment. This proposed pilot project will provide valuable preliminary data in investigating CEFALY for effective at-home treatment of pediatric migraine, with the potential to minimize treatment side effects, provide timely pain relief, and make treatment more accessible.