Non-invasive vagus nerve stimulation in Primary Sjogrens Syndrome
Research type
Research Study
Full title
The effect of non-invasive vagus nerve stimulation on immune responses in patients with primary Sjögren's syndrome
IRAS ID
185988
Contact name
Wan-Fai Ng
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
Previous animal studies have shown that stimulating the vagus nerve may have beneficial effects in inflammatory conditions through regulating immune responses. However, whether stimulating the vagus nerve can also regulate immune responses in humans is not clear.
ElectroCore LLC® have an approved CE marked device that can deliver stimulation to the vagus nerve safely and non-invasively in humans. The device is currently on the market in Europe for reducing symptoms of depression, as treatment or prevention of headache, as an adjunctive therapy to reduce the symptoms of gastric motility disorders and irritable bowel syndrome and as an adjunctive therapy in the prevention of partial onset and generalized seizures associated with epilepsy. The device works by delivering a short, low voltage electric stimulus to the vagus nerve in the neck.
ElectroCore LLC has recently completed a study showing that non-invasive vagus nerve stimulation using the gammaCore® device can reduce the inflammatory responses of immune cells collected from healthy volunteers. The aim of this pilot study is to examine the effects of vagus nerve stimulation (using electroCore's gammaCore® device) on immune responses measured from white blood cells collected from patients with Primary Sjogrens Syndrome (a condition in which the fine tuning of the immune system is defective). One of the reasons for choosing primary Sjogren's syndrome as the disease model is that it is a "bona fide" autoimmune condition. Furthermore, since no effective treatment is available for this condition, most patients are not on powerful medications that affect the immune system which in turn which will interfere with the interpretation of the results of the study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0379
Date of REC Opinion
23 Dec 2015
REC opinion
Further Information Favourable Opinion