STIMARA
Research type
Research Study
Full title
Non-invasive Vagal Nerve Stimulation Neurobiological Mechanism of Action in Rheumatoid Arthritis
IRAS ID
288481
Contact name
Neil Basu
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Patients suffering with chronic inflammatory disorders, such as rheumatoid arthritis (RA), commonly experience a range of symptoms collectively known as “sickness behaviours”. These include mood changes, fatigue, social withdrawal, increased pain and cloudy thinking. The burden of these symptoms has a negative impact on quality of life and contributes to bad disease outcomes. We need to better understand how the brain generates sickness behaviours in RA if we are to develop new and more effective treatments in future.
Using advanced brain scanners, we have been among the first to show a that alterations in the brain may cause sickness behaviours. The relationship between arthritis and the brain is complex, however one route of communication is through the vagus nerve. The vagus nerve carries messages between the brain and body and studies have shown that mild electrical stimulation of the vagus nerve can benefit patients with certain types of epilepsy and depression. Preliminary data from other studies has also shown this method of treatment could be beneficial to reduce joint pain in patients with RA. What remains unknown, is how non-invasive vagus nerve stimulation can alter the brain in RA and whether this is associated with reduction of sickness behaviours.
In this study we are exploring how non-invasive vagus nerve stimulation (niVNS) works in two groups of patients with RA, those who have only partially responded to their standard treatment and those with stable disease but who still have problems.
This study seeks to provide evidence that niVNS treatment (using the Vorso STIM100 system) alters specific regions of the brain, which are thought to be related to the generation of sickness behaviours.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0052
Date of REC Opinion
25 Mar 2021
REC opinion
Further Information Favourable Opinion