Quick Summary
- In 2023, an Australian patient became the first person to receive Salvia BioElectronics’ ultra-thin implant as part of early research into neuromodulation for severe headache disorders.
- Cluster headache and migraine are separate neurological conditions.
- Research has continued, including a new Dutch study called RESPONSE-II investigating the treatment in people with chronic cluster headache.
- The device remains investigational. It is not an approved treatment and there is not yet enough evidence to know how effective it will prove to be.
- Established treatments remain important. European guidelines continue to strongly recommend high-flow 100% oxygen as one option for treating acute cluster headache attacks.
When we first reported on a new neurostimulation implant in 2023, it was genuinely an interesting moment in cluster headache research.
A 29-year-old woman in Australia had become the first patient to receive an ultra-thin implant developed by Dutch medical technology company Salvia BioElectronics. Early reports from the company described improvements in the frequency and intensity of her attacks.
Three years later, we can look at that development with a little more perspective.
The technology has not become a standard cluster headache treatment. Nor can it be described as a cure. What has happened, however, is arguably more interesting: clinical research has continued, and a new study is now investigating the technology specifically in people with chronic cluster headache.
So where does the research stand in 2026?
First, cluster headache is not a type of migraine
This is an important correction to our original 2023 article.
Cluster headache and migraine can both cause severe head pain, but cluster headache is not a severe form of migraine. It is a separate primary headache disorder with its own characteristic symptoms and patterns.
Cluster headache attacks tend to cause extremely severe pain on one side of the head, frequently around or behind one eye. They may be accompanied by symptoms such as watering of the eye, nasal congestion, a drooping eyelid or facial sweating.
Another characteristic is the pattern. Attacks can occur repeatedly, sometimes several times within 24 hours, and may follow remarkably regular daily or seasonal cycles.
People with chronic cluster headache have an especially difficult form of the condition because they do not experience the long periods of remission associated with episodic cluster headache.
For a more detailed patient-focused explanation of the condition, MyClusters has a useful introduction to what cluster headaches are.
That distinction matters when discussing new research. A treatment being studied for migraine cannot automatically be assumed to work for cluster headache, and vice versa.
What is neurostimulation?
Neurostimulation uses controlled electrical impulses to influence activity in specific nerves.
This is not a completely new idea. Different forms of nerve stimulation have already been investigated for a range of neurological conditions. What made the Salvia development unusual was the design of the system.
The company’s current MySalvia Therapy uses very thin implants positioned beneath the skin around targeted nerve areas in the forehead and back of the head. An external wearable device is then used to activate the stimulation.
The intention is to target nerve pathways thought to be involved in severe headache disorders.
For someone living with frequent chronic cluster headache attacks that have not responded adequately to conventional treatment, it is easy to understand why this approach attracts attention.
But that is also where caution becomes important. An interesting mechanism and an encouraging result in one patient are not the same as evidence that a treatment is effective across a wider group of people.
What actually happened in 2023?
Salvia BioElectronics announced its first implantation in July 2023.
The procedure involved the implantation of ultra-thin bioelectronic foils as part of the company’s early clinical research. The first patient was a 29-year-old woman in Australia who had lived with debilitating headaches since adolescence.
The company subsequently reported an immediate improvement in the number and intensity of her attacks.
That was clearly encouraging for the patient involved. It also represented an important technical milestone for the researchers. However, it was still the experience of the first patient.
Our original article described the event as a breakthrough. Looking back from 2026, a better description would be an important first step in establishing whether this form of neuromodulation could eventually become useful for some people with difficult-to-treat headache disorders.
The next question was always going to be whether the results could be reproduced in more patients.
What has happened to the cluster headache research since then?
The research programme has continued.
Salvia now lists its original 2023 RESPONSE study in Australia as its first evaluation of the therapy in people with chronic cluster headache. Recruitment for that study has finished, although the therapy remains under investigation.
More significantly for cluster headache research, a second study began in the Netherlands in March 2026.
Called RESPONSE-II, the study is investigating combined trigeminal and occipital nerve stimulation as a preventive treatment for chronic cluster headache.
According to the current RESPONSE-II clinical trial record, up to 15 participants are expected to take part across two centres in the Netherlands. The study is aimed at people with chronic cluster headache who have not responded adequately to verapamil.
Researchers are looking at safety, potential clinical benefit and the experience of participants using the system.
You can also see the current programme on Salvia BioElectronics’ clinical studies page.
That is meaningful progress from where the story stood in 2023. But we need to say that it is also still early-stage research.
Does this mean an implant is now available for cluster headaches?
No and this is probably the most important practical point.
Salvia itself describes MySalvia Therapy as an investigational device. It has not been approved for general commercial use, and the company states that it is not yet making claims about its safety or effectiveness.
RESPONSE-II is a feasibility study. Its purpose is to generate evidence, not to demonstrate that the question has already been answered.
We therefore cannot say at this stage whether the treatment will eventually be suitable for a wider group of people with chronic cluster headache.
Important questions remain.
- How much can treatment reduce attack frequency?
- Does it reduce attack severity?
- How consistent is the effect between patients?
- How well is the implant tolerated?
- Does any improvement continue over the longer term?
- And perhaps most importantly, which people with chronic cluster headache, if any, are most likely to benefit?
Those answers require clinical evidence.
Where does oxygen fit into cluster headache treatment?
While experimental treatments attract understandable interest, they should not distract from the treatments already used in clinical practice.
The European Academy of Neurology’s guideline on cluster headache makes a strong recommendation for 100% oxygen at a flow of at least 12 litres per minute as one treatment for acute cluster headache attacks. Subcutaneous sumatriptan is another strongly recommended acute treatment.
The precise treatment an individual uses should, of course, be decided with their neurologist or headache specialist.
Oxygen has a particular role because it is an acute treatment. It is used when an attack begins rather than as a preventive treatment designed to stop future attacks occurring.
That also explains why cluster headache oxygen can present unusual practical problems when travelling.
Someone might not require oxygen continuously, yet when an attack occurs they may need access to a high continuous flow immediately. A small portable oxygen concentrator designed for low-flow or pulse-dose oxygen may therefore be completely inappropriate for that particular prescription.
If you already use prescribed high-flow oxygen and are considering travelling, our guide to High Flow Oxygen for Cluster Headaches: Can You Travel Without Worry? explains the practical issues in much greater detail.
We also have a broader guide to travelling with high-flow oxygen if your oxygen requirements are more complex.
Research is not only about new treatments
New implants naturally attract headlines, but another part of cluster headache research is much less dramatic: understanding what happens to people between hospital appointments.
When do attacks occur?
How long do they last?
Are patterns changing?
What treatments were used during individual attacks?
Are there seasonal or daily patterns that only become apparent when attacks are recorded over time?
This is one reason we have recently started working with MyClusters, a patient-focused cluster headache tracking and research platform. MyClusters enables people to record their attacks and analyse their own patterns, while users can also choose to contribute anonymised data to research.
The importance of recording attacks is explained particularly well in the MyClusters article Why Track Your Cluster Headaches?.
For someone living with an unpredictable condition, tracking does not make the attacks disappear. But having a reliable record can make it easier to discuss patterns, treatment responses and changes with a healthcare professional.
It can also give researchers access to something that is difficult to reproduce in a clinical setting: detailed information about how cluster headaches behave in everyday life.
What should we watch for next?
The important development since our original 2023 article is not that neurostimulation has “solved” cluster headache.
It has not.
The important development is that an intriguing first procedure has progressed into a continuing clinical research programme.
RESPONSE-II should help researchers learn more about whether combined stimulation of targeted nerve areas can offer meaningful preventive benefit for people living with chronic cluster headache who have not responded adequately to established treatments.
That is exactly the sort of evidence that was missing when the first patient story appeared in 2023.
Until stronger results become available, the sensible position is one of cautious interest.
For people living with cluster headaches today, good specialist care, an appropriate acute and preventive treatment plan, and practical preparation remain essential.
And if prescribed high-flow oxygen forms part of that treatment and you would like to travel, planning ahead makes an enormous difference.
OxygenWorldwide can check what oxygen can be arranged at your destination, coordinate with your hotel, apartment or private accommodation, organise delivery and collection, and help plan refills where the service is available.
If this is your first time arranging oxygen away from home, you can also read our guide to travelling abroad with medical oxygen.
When you are ready to plan your trip, fill in the OxygenWorldwide travel form with your destination, dates and existing oxygen requirements and we will guide you from there.
Key Takeaways
The neurostimulation story that began with the first Salvia implant in 2023 has developed into a genuine clinical research programme, including the RESPONSE-II chronic cluster headache study launched in the Netherlands in 2026. That is encouraging, but the technology remains investigational and should not yet be described as an established treatment or a cure.
For people living with cluster headache today, current treatment and good preparation remain more immediately relevant. High-flow oxygen continues to have an established role in treating acute attacks when prescribed by a healthcare professional, while tracking attacks through resources such as MyClusters can provide useful information about patterns and treatment response.
If prescribed oxygen is part of your treatment and you are planning a trip, fill in the OxygenWorldwide travel form early so the destination arrangements can be checked properly.
Frequently Asked Questions
Is neurostimulation an approved treatment for chronic cluster headache?
The Salvia system discussed in this article is currently investigational and is being evaluated through clinical studies. It should not be regarded as an approved, generally available treatment for chronic cluster headache.
Is the Salvia implant a cure for cluster headache?
No. There is currently no evidence that supports describing the implant as a cure. Researchers are investigating whether this type of nerve stimulation can reduce the frequency or severity of attacks in selected people with chronic cluster headache.
What is the RESPONSE-II cluster headache study?
RESPONSE-II is a clinical feasibility study that began in the Netherlands in March 2026. It is investigating combined trigeminal and occipital nerve stimulation in people with chronic cluster headache who have not responded adequately to verapamil. Up to 15 participants are expected to take part. The RESPONSE-II study record is available on ClinicalTrials.gov.
Does neurostimulation replace oxygen treatment?
No. These are different approaches. Neurostimulation is being investigated as a preventive treatment, while high-flow oxygen is an established acute treatment used when a cluster headache attack occurs. Your neurologist or headache specialist should determine which treatments are appropriate for you.
Our article on high-flow oxygen for cluster headaches and travel explains the practical implications for people who already have prescribed oxygen.
Can I travel if I use high-flow oxygen for cluster headaches?
Often, yes, provided suitable oxygen can be arranged at your destination. High-flow cluster headache treatment has particular equipment and supply requirements, so arrangements should be checked well before travel.
OxygenWorldwide does not provide oxygen inside aircraft cabins or at airports, but can arrange destination oxygen in many locations where the required service is available.
The best starting point is to complete the OxygenWorldwide travel form with your destination, dates and prescribed oxygen requirements.
Summary
Neurostimulation is being investigated as a possible preventive treatment for people with chronic cluster headache who have not responded adequately to established therapies. Salvia BioElectronics first implanted its ultra-thin neurostimulation system in 2023 and began the RESPONSE-II feasibility study in the Netherlands in March 2026. The technology remains investigational and is not an approved treatment or cure. Established treatments therefore remain important, including high-flow oxygen for acute attacks when prescribed by a healthcare professional. Attack tracking through platforms such as MyClusters may also help patients and researchers understand patterns and treatment responses.
