Rheumatoid Arthritis (RA
Conditions
Keywords
non-invasive vagus nerve stimulation, rheumatoid athritis, heart rate variability, splenectomy
Brief summary
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
Detailed description
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.
Interventions
24 months self-administrated trans-auricular vagus nerve stimulation in an asplenic patient.
Sponsors
Osteoflow Health Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
n-of-1 longitudinal study
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* diagnosed RA * splenectomy
Exclusion criteria
Pharmaceutical treatment as: * disease-modifying antirheumatic drugs (DMARDs) * Biologics * Jak inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Simple Disease Activity Index (SDAI) for Rheumatoid Arthritis | From enrollment to the end of treatment at 24 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the sympathovagal balance | From enrollment to the end of treatment at 24-month | 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 |
Countries
Canada
Outcome results
None listed