Non-invasive vagus nerve stimulation trial in functional gastrointestinal disorders
Study to assess symptom improvement in patients with IBS and functional dyspepsia
Following a successful proof of concept assessment in patients with gastroparesis, a clinical trial is commencing to treat patients with two of the most-common gastrointestinal (GI) complaints, Irritable Bowel Syndrome (IBS) and functional dyspepsia.
The trial, which is being held at the Royal Free Hospital in London, is a double-blind, parallel, sham-controlled trial involving 80 patients and using electroCore's non-invasive vagus nerve stimulation (nVNS) therapy. Results are expected in the first quarter of 2015.
The proof of concept assessment was undertaken in severely-ill patients that had gastroparesis awaiting surgical implantation of a gastric pacemaker and suffered with chronic daily headaches, for which electroCore’s gammaCore nVNS therapy is approved. The assessment suggests that electroCore's nVNS therapy reduced feelings of nausea, early satiety and bloating. A continuation of the assessment programme is underway to further analyse the effects of nVNS in these extremely unwell patients.
The formal pilot trial will be split into two groups, 40 patients with IBS and 40 with functional dyspepsia. Each group of 40 patients will be randomised, with half the patients receiving electroCore’s gammaCore device, which delivers the active non-invasive stimulation, while the other half will use a sham device. The randomised comparative period of four weeks will be followed by a four week open-label period where the patients using the sham device will switch to an active gammaCore device. The patients already on gammaCore will continue to receive the active therapy.
The study, led by Professor Owen Epstein, has as a primary objective - the assessment of symptom improvement in patients with IBS and functional dyspepsia.
During the trial the patients will self administer the therapy by placing the gammaCore device on the skin surface overlying the vagus nerve in the neck. During the first four weeks, the treatment consists of four 120-second stimulations delivered as two consecutive doses to each side of the neck, three times a day. All the patients will continue to take their existing medications.
In the second four-week period, the sham group will switch to the active therapy on the same dosage regimen. The original active group will have the option to increase the number of stimulations from four to six doses three times daily for a total of 18 stimulations per day.
Functional dyspepsia and IBS account for up to 50% of specialist consultations in gastroenterology.
JP Errico, chief executive and founder of ElectroCore, said: “We were delighted to hear about the additional benefits observed in a group of gastroparesis patients who were being treated for headache. We now look forward to launching this pilot study in a wider group of patients as there is a real need for an effective treatment for IBS and functional dyspepsia. Our therapy has the great benefit of not having any serious side effects and can be used in conjunction with other treatments. We look forward to building on the initial success Professor Epstein has pioneered across a variety of GI disorders.”
