None listed
Conditions
Brief summary
Transcutaneous auricular vagus nerve stimulation (taVNS), a type of neuromodulation, is a potential non-pharmacological alternative to manage pain. Vagus nerve stimulation activates several brainstem regions involved in descending pain inhibition likely increases the release of endogenous opioids, may alter nociceptive processing at a cortical level and has anti-inflammatory effects. In addition, the ability to deliver taVNS in synchronisation with the exhalation phase of the respiratory cycle is likely to improve its application for pain management. Activity in the vagal brainstem nuclei is cyclically modulated by respiration. Recent functional magnetic resonance imaging (fMRI) studies have shown exhalation respiratory-gated auricular vagal nerve stimulation (eRAVANS) evoked fMRI signal increase in brain regions associated with enhanced VN activity and descending pain modulation. This study will explore if a prototype respiratory gated taVNS device is feasible to be used in a future single-centre clinical trial of home-based taVNS in people with rheumatoid arthritis.
Interventions
A single-arm, repeated measures feasibility study will be undertaken. Participants will receive 14 sessions of daily respiratory-gated transcutaneous auricular Vagus Nerve Stimulation (taVNS) for 20 minutes. Two of these sessions on day 1 and day 8 will be supervised and take place at North Shore Hospital, as part of an assessment session, while 12 of these sessions will be completed unsupervised, in the participant’s home.
The supervised sessions will be administered by the study co-investiga
A single-arm, repeated measures feasibility study will be undertaken. Participants will receive 14 sessions of daily respiratory-gated transcutaneous auricular Vagus Nerve Stimulation (taVNS) for 20 minutes. Two of these sessions on day 1 and day 8 will be supervised and take place at North Shore Hospital, as part of an assessment session, while 12 of these sessions will be completed unsupervised, in the participant’s home. The supervised sessions will be administered by the study co-investigator. As part of the induction during the first supervised session (day 1), participants will be trained on 1. How to insert the earpiece with the stimulation electrodes in the left ear with the electrode pins resting at the cymba concha; 2. How to position the heart rate sensor on the left index finger; 3. How to wear the respiration sensor strap just under their rib cage. A user application, developed to accompany the prototype system, will be loaded on a mobile tablet that will be supplied to the participant. The application will instruct the participant to be seated in a chair and fit the equipment appropriately. It will check that the equipment is being worn correctly and is transmitting the data to the application. Each participant will set the taVNS stimulation intensity in the application to ensure it is strong but not uncomfortable. During each taVNS session, the stimulation will be administered at 30 Hz for 1 second during exhalation only for a total of 20 minutes after which the session will be completed. The co-investigator will monitor the usage of the device and application as the participants progress through the intervention. If they miss a single session, they will be sent a follow-up text message and email as a reminder to complete the next session. If they miss 2 consecutive sessions, they will receive a call the next day to remind them to continue with the training and address any issues they may be experiencing with the equipment.
Sponsors
Exsurgo Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed