Neuromodulation Devices for the Treatment of Migraines

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Dec 6, 2023

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Running head: NEUROMODULATION FOR MIGRAINES 1 Neuromodulation for the Treatment of Migraines Michelle S. Cerroni Saint Joseph’s College of Maine

NEUROMODULATION FOR MIGRAINES 2 Neuromodulation for the Treatment of Migraines Migraines are one of the most common illnesses and can be highly debilitating to those that suffer from them. “Migraine affects more than 10% of the general population and is one of the most prevalent medical conditions in the world” (Yuan & Chuang, 2021). Until recently, treatment options were primarily limited to pharmaceuticals that are often ineffective or have intolerable side effects. Around the turn of the twenty-first century, neuromodulation devices, which stimulate the nerves involved in migraines, were developed and proven as safe, effective treatment modalities. “In the last two decades, noninvasive neuromodulation devices have become an effective alternative to pharmacological treatment for migraine due to a better mechanistic understanding of headache pathophysiology and burgeoning technological advances” (Yuan & Chuang, 2021). Several FDA-approved devices are discussed in this paper. One of the most common FDA-approved neuromodulation treatments for migraines is TENS (transcutaneous electrical nerve stimulation) units. The idea of utilizing electricity to ease pain is a familiar one. “TENS, in its earliest conceptual form, is believed to date back to approximately 60 A.D. The Roman physician Scribonius Largus proposed symptomatic relief to patients by having the patient be exposed and in contact with an ‘electric fish’ from the ocean” (Teoli, D & An, J.). However, the TENS units as we know them, have only been around since the 1970s and “are credited to American neurosurgeon Dr. C. Norman Shealy” (Teoli, D & An, J.). The first FDA-approved TENS unit for migraine prevention and treatment is Cefaly. “The Cefaly device is an external trigeminal nerve stimulation device (e-TNS) that transcutaneously excites the supratrochlear and supraorbital branches of the ophthalmic nerve (V1) via a bipolar self-adhesive electrode (30 x 94 mm) applied to the forehead” (Urits et al., 2020). Research studies comparing Cefaly to other migraine treatments have shown it to be a safe, effective

NEUROMODULATION FOR MIGRAINES 3 option. Unlike pharmaceuticals, neuromodulation devices cannot lead to overdose, chemical dependence, or systemic side effects. “Among tested devices, several are already approved for clinical use, such as the TENS device, called Cefaly™, which is C.E. marked and FDA cleared. Based on current evidence, it appears to be useful for preventive treatment and possibly acute treatment” (Moisset et al., 2020). Another class of neuromodulation devices is implanted in the skin and targets the vagus or occipital nerves with smartphone integration. “The NEMOS device is a recently developed neuromodulatory technique that applies a wireless, wearable, non-invasive device controlled by a smartphone application, which stimulates the peripheral nerves of the upper arm. It is an effective, well tolerated, and safe non-pharmacological method for acute treatment in CM (chronic migraine)” (Szok et al., 2023). Compared to typical pharmaceutical treatments for migraines, neuromodulation devices provide a cost-effective alternative. Botox can cost over one-thousand dollars every three months, depending on insurance coverage. “Cefaly is available OTC. It can be bought from their website for $379” (Aungst, T, 2021). Some other neuromodulation devices can range up to a couple of thousand dollars. However, when used with other therapies, these devices can limit emergency services, which are costly to both the patient and the healthcare system. They can also reduce the medication needed to control migraines, saving patients money. As neuromodulation technology progresses, they are evolving from a therapeutic tool to a method of obtaining previously hidden data within the human body, altering the course of treatment. The treatments mentioned above have been open-loop systems. However, current and emerging closed-loop systems react to biological stimuli and can provide valuable insight. “Responsive, or closed-loop, neuromodulation systems adjust stimulation according to a

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