A feasibility study of non-invasive auricular vagus nerve stimulation in people with rheumatoid arthritis.
- Conditions
- rheumatoid arthritis (RA)Inflammatory and Immune System - Rheumatoid arthritisAnaesthesiology - Pain management
- Registration Number
- ACTRN12624000620527
- Lead Sponsor
- Exsurgo Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
Males and females 18 years of age or older who have been diagnosed with adult-onset rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR)/ the European Alliance of Associations for Rheumatology (EULAR) 2010 RA classification criteria; have the presence of at least 3/28 swollen and/or at least 3/28 tender joints with 1 tender joint being in the hand or wrists
Participants will be excluded from the study if they have any of the following:
•Ear infection (otitis media or otitis externa)
•Poor hand dexterity and no access to a helper at home who could assist in fitting the in-ear taVNS device and the respiration sensor strap
•Changes in oral or biologic disease-modifying antirheumatic drugs (DMARDs) in the last 4 weeks
•Have had intraarticular or intramuscular corticosteroids within 2 weeks prior to study entry
•Unstable dosing regimen of non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics in the last 2 weeks
•History of arrhythmia, myocardial infarction in the last 12 months, currently on beta-blocker medication or history of stroke affecting the brainstem
•Previous vagotomy
•Currently implanted electrical and/or neurostimulator device
•Active malignancy or history of active malignancy in the last 2 years, with the exception of non-melanoma skin carcinoma or carcinoma in situ
•Severe comorbidities which in the judgement of the study physicians would deem the participant not suitable as it may impact the safety of study conduct
•Known cognitive impairments
•Psychiatric illness with active psychosis
•Pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method