A feasibility study of non-invasive auricular vagus nerve stimulation in people with rheumatoid arthritis.

Exsurgo Ltd0 个研究点目标入组 12 人开始时间: 2024年5月14日最近更新: 2024年9月9日

适应症

试验速览

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•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

发起方

Exsurgo Ltd