The paper also found that nVNS therapy resulted in meaningful improvements in quality of life and a reduction in the use of traditional rescue medications such as injectable Sumatriptan and oxygen.
Cluster headache is an extremely painful condition that affects approximately the same number of people as multiple sclerosis, and is considered by experts to be one of the most painful medical conditions known to medicine.
The key findings of the study were:
- Patients receiving nVNS therapy plus standard of care had 5.9 fewer weekly cluster attacks compared with a 2.1 attack reduction (p=0.02) in patients who were not given gammaCore.
- Forty percent of the patients using gammaCore had a ≥ 50% reduction in their weekly attacks compared with 8.3% of those in the SoC group – a 33% improvement (p<.0.001).
- Treatment with nVNS was more effective the longer patients remained on therapy.
- The quality of life measurement – EQ-5D-3L VAS2 – indicated a significant improvement with nVNS over the baseline measurement.
- Patients on nVNS (in the randomized phase) reduced their use of sub cutaneous Sumatriptan and oxygen by >60% while those in the control group did not experience a substantial reduction in abortive medication use.
- At the end of the study 65% stated that they would recommend nVNS to others.
- 75% of patients rated nVNS as easy to use.
- Treatment with nVNS was safe and well tolerated with no serious device related adverse events.
Dr. Charly Gaul, Director of the Migraine and Headache Clinic in Königstein, Germany, who was the principle investigator of the PREVA trial commented, “Current prophylactic treatments for cluster headache are limited with verapamil and lithium used most often. These drugs have significant side effects. Our study demonstrates the clinical relevance of nVNS in patients with chronic cluster headache and adds an easy to use and an important new option for this extremely painful and difficult to manage condition.”
The patients in the study delivered the therapy by holding electroCore’s gammaCore device on the neck over the vagus nerve (gammacore.com). The patients carried out the 120 second stimulation three times in the morning and three times in the evening with a gap of five minutes between stimulations. The stimulation is achieved by a proprietary electrical signal that activates specific fibers in the vagus nerve bundle.
Vagus nerve stimulation as a surgical procedure has been around for more than twenty years for the treatment of epilepsy. However the high cost – around $30,000 – and invasiveness of surgically implanted pacemaker-like devices had relegated VNS therapy to the end of the continuum of care. US healthcare company electroCore’s non-invasive VNS delivery technology has shifted the paradigm, and the use of VNS is being found to be effective in treating a number of conditions.
The gammaCore therapy is presently available in Europe, with a physician’s authorization, under a CE mark covering the treatment and prevention of primary headaches, including both migraine and cluster headache.
Notes to editorsThe PREVA trial:
The PREVA trial which is part of the largest trial program ever carried out in cluster headache, was conducted at ten sites across Europe with 97 patients enrolled. Ninety-three were randomized to participate following the initial baseline data collection. Forty-five of the patients were randomly selected to use gammaCore plus their usual treatment and 48 to the best available standard of care. The baseline data collection period was two-weeks, followed by the four-week randomized phase. All the patients from both arms were asked to continue on active therapy for an additional four-week open label phase.
The Cephalagia paper is available online at http://cep.sagepub.com/
1 A diagnostic and treatment process that a clinician should follow for a certain type of patient, illness, or clinical circumstance.
2 The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.