Migraine is a common neurological condition associated with intense headaches and other debilitating symptoms. It is primarily managed with medications, including drugs for acute treatment (when a migraine occurs) and migraine prevention. Migraine medications don’t work for everyone, and some people struggle with side effects or contraindications, limiting their use. In addition, excessive use of acute migraine medications can result in medication overuse headache. Fortunately, various non-medication treatment options are available or in development.
In this article, we discuss nerve stimulation as a drug-free treatment option for migraine. Nerve stimulation, also known as neurostimulation or neuromodulation, is a form of therapy in which electrical current or magnetic fields are applied to nerves of the central or peripheral nervous system to disrupt pain pathways and other processes associated with migraine. Nerve stimulation includes non-invasive options, as well as implantable systems for more severe, hard to treat migraine.
For more information about migraine symptoms, triggers, and causes, read our previous article. To learn more about medications for migraine relief, read this article.
Non-Invasive Nerve Stimulation
Non-invasive nerve stimulation involves the application of gentle electrical or magnetic pulses to the skin to target specific nerves involved in migraine. Current treatment options include transcutaneous electrical nerve stimulation (TENS) specifically for migraine, and other neurostimulation devices. The following devices have demonstrated the potential to provide relief of migraine in clinical trials. Some, but not all, of these are available in Australia.
Supraorbital Transcutaneous Trigeminal Nerve Stimulation
The trigeminal nerve connects parts of the face to the brainstem and plays a key role in many cases of migraine. Supraorbital Transcutaneous Trigeminal Nerve Stimulation, also known as External Trigeminal Nerve Stimulation (eTNS), targets the branches of the trigeminal nerve that affect the forehead, scalp, and eyelids. The therapy uses a small, wearable TENS device placed on the forehead, just above the eye sockets.
- A wearable eTNS device is approved for acute and preventative treatment of migraine in adults in the US, Europe, Canada, and Australia.
External Concurrent Occipital and Trigeminal Neurostimulation
The occipital nerves are located at the back of the skull, from the neck upwards. Inflammation or irritation of these nerves, especially the greater occipital nerve, can cause several types of headaches and migraine. External Concurrent Occipital and Trigeminal Neurostimulation (eCOT-NS) uses a wearable circlet-like device placed around the head to target both the trigeminal and occipital nerves at the same time.
- eCOT-NS is approved for acute treatment of migraine in adults in the USA and Europe. It is not available in Australia.
Non-Invasive Vagus Nerve Stimulation
The vagus nerve is a long nerve that runs from the brainstem, down the sides of the neck, to various organs, including the heart, and digestive system. It plays a key role in pain regulation. Non-Invasive Vagus Nerve Stimulation (nVNS) uses a handheld device to stimulate the vagus nerve externally through the neck. Originally used to treat epilepsy, nVNS has also been found to help reduce migraine systems.
- A handheld nVNS device is approved for acute and preventative treatment of migraine in the USA, Europe, and Australia.
Remote Electrical Neuromodulation
Remote Electrical Neuromodulation (REN) offers an alternative to stimulation of nerves in the head. Instead, non-painful electrical stimulation is applied to nerves elsewhere in the body, such as the arm. This activates a natural pain mechanism called “conditioned pain modulation”, which can help reduce migraine headache. A smartphone-controlled REN device has been developed that stimulates the upper arm via an armband with rubber electrodes and a power source.
- The REN device is approved for acute and preventative treatment of migraine in adolescents (12+ years) and adults in the USA and Europe. It is not available in Australia.
Single-Pulse Transcranial Magnetic Stimulation
Single-Pulse Transcranial Magnetic Stimulation (sTMS) is a non-invasive therapy that uses magnetic pulses to stimulate nerve cells in the brain. Portable devices have been developed that are held at the back of the head to stimulate the outer layer of the brain (the cortex). This is believed to interrupt a process called “cortical spreading depression”, which is linked to brain hyperexcitability and migraine aura.
- sTMS is approved for acute treatment of migraine with or without aura in adults in the USA, Europe, Canada, and Australia. It is also approved for preventative treatment in the USA. It cannot be used in people with epilepsy or a history of seizures.
- A mini version of the device is approved in the USA and Europe for acute and preventative treatment of migraine.
Implantable Nerve Stimulation Systems
Implantable nerve stimulation systems have been used for many years to treat severe neurological conditions. These systems are recommended for people with severe, chronic, debilitating migraine who can’t tolerate or don’t respond to medications and standard treatments. The implant surgery is minimally invasive, as the devices are so small that they can be inserted through small incisions in the head.
Occipital Nerve Stimulation
Occipital Nerve Stimulation (ONS) involves a non-destructive surgical procedure in which electrodes are implanted under the skin within the occipital region (located at the base of the skull at the back of the head). The electrodes are connected to an implanted stimulator placed in the chest, abdomen, or buttocks. A remote control is used to adjust the stimulation and recharge the device. The device provides continuous stimulation to the occipital nerves, which is thought to activate pain-inhibiting systems and restore pain control.
- Currently, ONS is only approved for the treatment of chronic, refractory migraine in Europe.
Combined Occipital Nerve and Supraorbital Nerve Stimulation
Combined Occipital Nerve (ON) and Supraorbital Nerve (SON) Stimulation is a newly developed treatment for chronic migraine sufferers who have tried standard treatment options without success. It simultaneously stimulates the occipital and trigeminal nerves to disrupt the major migraine pain pathways and provide better coverage of pain across the head. Currently, a new device is being evaluated in clinical trials. The device is the first migraine system to be fully implanted in the head region.
- The device is currently only available to clinical trial participants in the USA and Australia.
Clinical Trials for Migraine
Here at Genesis Research Services, we regularly conduct clinical trials involving new migraine treatments. To view our currently recruiting studies or register your interest for future studies, click here, or call us on (02) 4985 1860.
References & Resources:
Websites:
1. Headache Australia. https://headacheaustralia.org.au/
§ “Migraine Treatment Options”. https://headacheaustralia.org.au/migraine/treatment-options/
2. Migraine Australia. https://www.migraine.org.au/
§ “CGRP Therapies”. https://www.migraine.org.au/cgrp
3. The Migraine Trust: https://migrainetrust.org/
4. Philpott J. “ShiraTronics’ neuromodulation device reduces migraine frequency”. Clinical Trials Arena. 2024 July 17. https://www.prnewswire.com/news-releases/shiratronics-unveils-data-on-their-neurostimulation-system-for-chronic-migraine-302195859.html
5. Schwedt TJ, Garza I. “Acute treatment of migraine in adults.” UpToDate. 2023 Oct. https://www.uptodate.com/contents/acute-treatment-of-migraine-in-adults
Journal Articles:
1. Aguilar-Shea AL, Membrilla Md JA, Diaz-de-Teran J. Migraine review for general practice. Aten Primaria. 2022; 54(2): 102208.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8605054/
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3. Jenkins B. Migraine management. Australian Prescriber. 2020; 43: 148-51. https://doi.org/10.18773/austprescr.2020.047
4. Lloyd JO, Hill B, Murphy M, Al-Kaisy A, Andreou AP, Lambru G. Single-Pulse Transcranial Magnetic Stimulation for the preventive treatment of difficult-to-treat migraine: a 12-month prospective analysis. J Headache Pain. 2022; 23(1): 63. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9169440/
5. Oved D, Tepper SJ, Deutsch L, Sharon R. External Concurrent Occipital and Trigeminal Neurostimulation Relieves Migraine Headache: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial. Pain and Therapy. 2022; 11(3): 907-922. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314547/
6. Miller S, Sinclair AJ, Davies B, Matharu M. Neurostimulation in the treatment of primary headaches. Practical Neurology. 2016; 16(5): 362-75 https://doi.org/10.1136/practneurol-2015-001298
7. Ray JC, Macindoe C, Ginevra M, Hutton EJ. The state of migraine: An update on current and emerging treatments. Aust J Gen Pract. 2021; 50(12): 915-921. https://www1.racgp.org.au/ajgp/2021/december/the-state-of-migrain
8. Riederer F, Penning S, Schoenen J. Transcutaneous Supraorbital Nerve Stimulation (t-SNS) with the Cefaly® Device for Migraine Prevention: A Review of the Available Data. Pain and Therapy. 2015; 4: 135–147). https://doi.org/10.1007/s40122-015-0039-5
9. Synowiec A, Stark-Inbar A, Weinstein M, Ironi A, Mauskop A. One-Year Consistent Safety, Utilization, and Efficacy Assessment of Remote Electrical Neuromodulation (REN) for Migraine Treatment. Adv Ther. 2024; 41(1): 170-181. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796417/
Disclaimer: The information provided here may not be up-to-date and subject to change. For the most accurate and current information for your country, please check directly with the relevant regulatory authority.