The goal of this clinical trial is to learn if chronic self-administrated non-invasive vagus nerve stimulation works to improves the disease activity in a single asplenic patient suffering from rheumatoid arthritis. It will also learn about the safety of at-home chronic non-invasive vagus nerve stimulation. The main questions it aims to answer are: Does chronic non-invasive vagus nerve stimulation improves the disease activity? Does chronic non-invasive vagus nerve stimulation decrease CRP serum level? Does chronic non-invasive vagus nerve stimulation improve HRV and the sympathy-vagal balance? Participant will: Stimulate at home the left auricular branch of the vagus nerve for 24 months with three different protocol of stimulation (parameters and duration) Visit the clinic once every 2 months for checkups and tests Will have blood work for CRP level check every 8 months
The study used a repeated measures design. After instructions on the use of a standard nVNS device, the patient was given an "at-home" nVNS-treatment protocol for 24-month run-in period, that was divided in three 8-month treatment blocks where each block-period consisted of active nVNS with specific settings and daily stimulation time. Each block was divided in 4-time assessment i.e., AAAA-BBBB-CCCC, once every 2 months. No washout period was included.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
24 months self-administrated trans-auricular vagus nerve stimulation in an asplenic patient.
OsteoFlow Health Clinic
Moncton, New Brunswick, Canada
Change in the Simple Disease Activity Index (SDAI) for Rheumatoid Arthritis
the Simple Disease Activity Index (SDAI) for Rheumatoid Arthritis is measured using the online MDCalc (https://www.mdcalc.com/calc/2194/simple-disease-activity-index-sdai-rheumatoid-arthritis)
Time frame: From enrollment to the end of treatment at 24 months
Change in the sympathovagal balance
the sympathovagal balance is calculated using the ratio of the power in normalized units of LF/HF. The analysis is processed with Kubios HRV Premium 3.5.0 software
Time frame: From enrollment to the end of treatment at 24-month
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