Migraines: they are in your head

The toll of migraine

“People in the chronic category have at least eight days of migraines per month, with an average of 18 migraine days.” – Schobben

Migraine headaches affect approximately one billion people worldwide. These debilitating episodes vary in severity and frequency; they are occasional in some people and frequent in others. ​​Migraine can be triggered by a variety of stimuli, including light, sound and scent. It is not entirely clear why migraine occurs, but it has been correlated to a variety of genetic, environmental and pathological causes.

These factors lead to abnormal nerve activity and inflammation, resulting in excruciating headaches and a variety of other symptoms, including dizziness, vomiting and visual disturbances.

While some patients find relief with medications and even injections of Botox, which can temporarily paralyse muscles in the head and reduce neurological signals, a substantial number fail to respond to these interventions.

This refractory population, resistant to standard interventions, may suffer from significant disability. Some are unable to work or socialise due to the severity of the symptoms.

Another debilitating condition, cluster headache, has an even more severe impact. These painful episodes may affect up to 0.1% of the global population. They result in severe pain on one side of the head, occurring up to eight times a day. In some cases, there are periods of remission, though some people experience unrelenting symptoms.

The promise of implants

In 2017, Hubert Martens, Wim Pollet and Daniel Schobben founded Salvia BioElectronics with the goal of reducing migraine symptoms using an implanted device.

The team named their new company Salvia after the plant genus, which has been used throughout history as an analgesic. The company now has more than 50 people working on the technology.

The founders had previously developed a deep brain stimulation device for Parkinson’s patients (their company, Sapiens Steering Brain Stimulation, was acquired by Medtronic in 2014). They now work with neuromodulation, a technology that has previously been successful for people with Parkinson’s and epilepsy. Neuromodulation uses electric impulses to calm oversensitive nerves that are associated with migraine.

“It is not masking the pain,” Schobben says. “It is teaching the brain how to deal with stimuli.”

The team set out to create a device that circumvented the problems that had plagued earlier implementations. Traditional neurostimulation devices designed for implantation elsewhere in the body led to complications as they were not compatible with the anatomy of the head. Batteries needed to be regularly recharged or replaced altogether and the electrodes were relatively thick.

Because the devices had cables running underneath the skin in the neck, they could be pulled out of place by movement. Patients tended to fidget with the implants, displacing them and even pushing them through the skin, leading to infection and eventual removal.

A new approach

“When we started in 2017, we said: if we can make that entire system into a tiny device with electrodes as thin as paper, we would really be addressing a medical need.” – Schobben

The scientists decided to pursue a less invasive and less easily displaced mode of delivering the same treatment.

“The electrodes used in traditional devices are very thick at 1.3 millimeters, which is okay in soft tissue, but on the head, there is no space,” Schobben says.

They were committed to designing an unobtrusive model and ultimately landed on a bioelectronic foil that can be inserted just under the skin on the head. One portion is placed at the front of the head and the other, the back.

The final model is not perceptible to touch. The strip of foil is only 0.1 millimeters thick—as thin as a piece of paper. It is activated through a magnetic device that the user applies to the implanted electrode; it simply snaps on and is then removed. Salvia is currently developing an app that helps users manage the implant.

The minimally invasive device is inserted in a brief out-patient procedure. Once in place, the patient turns it on for an hour in the morning and an hour in the evening. Early feasibility studies show encouraging results, with patients improving over time as a result of the electrical impulses moderating their overactive nerves. Further clinical studies are needed to fully assess the device’s effectiveness and long-term safety.

Salvia has expanded the use of its technology to include treatment of cluster headaches as well. The implants have shown promise in reducing their severity and frequency.

Company milestones

“We have patients who have participated in our study for two years and they keep on improving.” – Schobben

In 2020, the technology received Breakthrough Device Designation from the United States Food and Drug Administration. This designation expedites the movement of devices that can alleviate severe or life-threatening conditions to market.

Salvia has received funding from both the European Innovation Council Accelerator programme and Netherlands Enterprise Agency (RVO) through Eureka’s Eurostars programme.

The company is now running clinical trials in order to assess the efficacy of the device, with the hopes of gaining approval and marketing it to migraine and cluster headache sufferers.

In 2023, patients in Australia and Belgium received implants for chronic migraine and cluster headache as part of early-stage trials. “One participant shared that, within a couple of months, she was doing things she hadn’t felt able to in a long time—like driving, spending time with family, and going on holiday,” says Schobben.

Additional patients have since received implants in Australia, Belgium and the Netherlands. The researchers are hopeful that this technology will soon be more widely available and offer relief to an underserved patient population.

Salvia’s migraine therapy is currently being evaluated in clinical studies. It has not yet been approved for commercial use. No claims are made regarding its safety or effectiveness.

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