Opinion

Neuromodulation and innovation: Pioneering the future of epilepsy treatment

By Michael Tittelbach, Chief Technology Officer, PRECISIS

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The field of neuromodulation is on the brink of a transformative era.

This medical technique, which alters nerve activity through targeted electrical stimuli, is projected to nearly double in size over the next five years, with the global market exceeding $11 billion.

With this double-digit growth year on year, hundreds of thousands of people will gain access to a variety of treatment options for a wide range of conditions, including pain, depression, urinary incontinence and more.

It is an exciting field of medicine, and the rate of technological advancement is expected to continue. 

Neuromodulation’s potential lies in its ability to provide precise, adjustable, and reversible interventions. Unlike traditional treatments, such as medication or surgery, neuromodulation can be fine-tuned to meet the unique needs of each patient, offering hope to those who have not responded to conventional therapies.

This is particularly crucial for epilepsy, where approximately 30 per cent of patients are resistant to drug treatments.

To put this into perspective, epilepsy affects around 80 million people worldwide.

Therefore, about 24 million individuals don’t respond adequately to conventional drug therapies.

An interesting dynamic in this growth is that European countries are leading the way in many of these developments.

        Michael Tittelbach

Onward Medical, a medical device company founded in Switzerland and now headquartered in the Netherlands, is pioneering the restoration of function in spinal cord injury patients.

Recent publications demonstrate their efficacy for both implantable and external devices.

Another innovative device comes from Precisis in Germany, which has developed an implantable electrode capable of treating focal epilepsy without major surgery.

Focusing on epilepsy, it is estimated that over 6 million people in Europe live with this neurological condition.

Fortunately, 70 per cent of epilepsy patients manage their symptoms with medication.

While there have been marginal advances in pharmacological treatments, such as Cenobamate, around 30 per cent of patients are considered to have drug-resistant epilepsy.

Historically, if the region of the brain causing seizures could be identified, patients might be offered a resection, a surgical procedure to remove that area of the brain.

However, resection can have significant impacts on the body’s function, potentially affecting motor skills, speech, memory, or other critical brain functions depending on the location and extent of the tissue removed.

A more conservative and tissue-sparing intervention currently garnering interest is neuromodulation.1

Several neuromodulation treatment options have been available for years.

Deep Brain Stimulation (DBS) involves drilling small holes in the skull and implanting electrodes within specific brain areas in the middle of the brain to manage drug-resistant epilepsy.

This is done even though epilepsy in most cases (around 70 per cent) has its source, the epileptic focus, sitting in the outer areas of the cortex.

DBS can be effective, but it comes with risks such as infection, bleeding in the brain, and potential side effects like speech or motor impairment due to the invasiveness of the procedure and the sensitive areas being targeted.

Vagus Nerve Stimulation (VNS), available for nearly 30 years, involves coiling an electrode around the vagus nerve in the neck to affect neurological activity in the brain.

These electrodes produce electrical impulses that can reduce seizures.

While VNS has an acceptable safety profile, it can still cause side effects such as hoarseness, throat pain, coughing, and difficulty swallowing.

Responsive Neurostimulation (RNS) is a relatively new development in epilepsy treatment.

This device requires electrodes to be placed deeply within the brain and directly onto the brain’s surface, necessitating multiple openings in the skull. 

RNS can detect brain waves, sense when a seizure is occurring, and deliver stimulation when assumed to be required.

RNS offers the advantage of responsive treatment, but it also shares risks similar to DBS, including surgical risks and potential for infection, as well as technical challenges like battery replacement and device malfunctions.

Pre implant diagnostics and implantation procedure are significant. 

While RNS is used in small numbers in the US, the company has no plans to bring the device to Europe.

Emerging Technologies and Innovations

New kids on the block

Focal Cortex Stimulation (FCS) is a new treatment option for focal epilepsy.

Developed by Precisis, the EASEE (Epicranial Application of Stimulation Electrodes for Epilepsy) system is placed under the skin without the need for drilling into the skull.

The EASEE system delivers a range of electrical impulses.

Early outcomes suggest that 65 per cent of patients previously unresponsive to conventional medical management experience clinically meaningful improvements.

The EASEE system, awarded its CE Mark in late 2022, is now available in Germany, the UK, Italy, Portugal, Austria, and Switzerland.

Improving diagnostics for epilepsy patients has also been an important emerging field with markable success in providing long term EEG recording and seizure detection devices.

One already available in European markets is UNEEG from Denmark, with others expected to come in the US and other territories, like Epiminder from Australia.

Both devices are slipped under the scalp and placed behind the ear to stream EEG recordings to the outside world, providing physicians with crucially important data which aims to help with better control and continuous improvement of therapies.

Further developments in Brain-Computer Interface (BCI) devices, such as Elon Musk’s Neuralink, are also showing promise.

Neuralink recently reported its first human trial, with the patient able to control a computer mouse using thoughts alone.

Aptly named “Telepathy”, this is one of many BCI companies pushing the boundaries of what is possible.

Combined with quantum leaps in AI integration and the work of thousands of dedicated healthcare professionals and scientists, the coming years in neuromodulation are set to be incredibly exciting, with the potential to help a wide range of conditions innovatively.

Back to epilepsy, recent advancements in neuromodulation treatment are expanding the boundaries of possibility.

Key innovations include closed-loop systems, wearable transcranial electrostimulation and optogenetics. 

Upcoming advancements – Closed-Loop Systems and Artificial Intelligence

Academia and most players on the epilepsy device market are aligned in the importance of investing in closed loop systems, adding online status monitoring of the affected brain areas as a therapy defining element.

More and more developments are moving towards artificial-intelligence and deep-learning based technologies, to improve algorithms used for detection of seizures or – even better – precursors of upcoming seizures in the EEG signals.

Conclusion

Neuromodulation represents a beacon of hope for millions of epilepsy patients who have not found relief through traditional treatments.

Through relentless innovation and technological advancement, we are moving closer to a future where epilepsy can be managed more effectively and with fewer side effects.

The journey is far from over, but the strides made in neuromodulation technologies highlight the incredible potential of human ingenuity in addressing one of the most challenging neurological disorders.

As we continue to explore and develop these innovative therapies, we pave the way for a future where epilepsy patients can lead fuller, healthier lives free from the debilitating effects of seizures.

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