Treating cluster headaches with vagus nerve stimulation

Cluster headache occurs in 0.1 per cent of the population and patients say it is the worst pain they have ever experienced, even more painful than childbirth, kidney stones, gunshot wounds, and appendicitis.

Non-invasive vagus nerve stimulation (nVNS) involves a device that stimulates the nerve with electrical impulses. Non-invasive approaches do not require surgical implantation and nVNS devices have been approved in Europe to treat epilepsy, depression and pain.

Experimental and basic neuroscience research at the National Institute for Health Research (NIHR) Maudsley Biomedical Research Centre has helped to better understand the processes underlying the beneficial effect of nVNS for pain.

Right: The Pain of Cluster Headache, Arte Cluster

National collaboration on clinical trials

We led a European-wide industry-funded study to test nVNS as a new treatment for cluster headache attacks. Patients were randomly selected to receive either nVNS or a similar procedure without vagus nerve stimulation (control group) so that neither the patients nor the researchers could knew which type of treatment had been delivered.

Patients were recruited through collaboration with the UK expert patient group (OUCH-UK), who advised on the methods and with our partner clinic at King’s College Hospital. We worked with colleagues in Liverpool, Hull and Glasgow, through our relationship with the NIHR Clinical Research Network, as well as with European colleagues.

 The results were very promising. Three times as many people with episodic cluster headache were pain-free within 15 minutes of receiving nVNS treatment compared to the control group. The device was well-tolerated, and OUCH-UK were impressed by the high level of patient acceptability.

The US-based company involved in the research, electroCore, specialises in stimulation technology - a highly suitable collaboration to further develop these cutting-edge approaches. The study has cemented the UK’s place as a first choice for such studies.

Pictured: The gammaCore device, a non-invasive neuromodulation therapy delivered by a hand-held unit that stimulates the vagus nerve through the skin, developed by electroCore.

Regulatory approval of non invasive vagus nerve stimulation

Our research contributed to the Food and Drug Administration approval of nVNS for cluster headache attacks in the US. In England, the data were examined in a National Institute for Health and Care Excellence guideline and nVNS is also now available on the NHS.

Building on our relationship with OUCH-UK and our UK collaborating sites, we will now examine new evidence-based treatments, to strive for further improvements in management of this devastating condition.



Involving Patients in Research | Novel Diagnostics and Therapeutics | Industry Collaboration | National and International Collaboration | Personalising Treatment to Patients