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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| n-of-1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans-auricular vagus nerve stimulation | Device | 24 months self-administrated trans-auricular vagus nerve stimulation in an asplenic patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment to the end of treatment at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 24-month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Neuro-immunological (NIM) Index | the neuro-immunological index express the effect of vagal modulation on inflammation and is the ratio of RMSSD / CRP | From enrollment to the end of treatment at 24-month |
Inclusion Criteria:
Exclusion Criteria:
Pharmaceutical treatment as:
Eligibility to participate in the study is limited to specific gender that aligns with the sex they assigned at birth.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OsteoFlow Health Clinic | Moncton | New Brunswick | E1C 5N3 | Canada |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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n-of-1 longitudinal study
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |