Effects of Non-Invasive Vagus Nerve Stimulation on Rheumatoid Arthritis: A Longitudinal Prospective Case Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosed RA
- •splenectomy
Exclusion Criteria
- •Pharmaceutical treatment as:
- •disease-modifying antirheumatic drugs (DMARDs)
- •Biologics
- •Jak inhibitors
Investigators
Pascal JD Grolaux
Principal Investigator
Universidad Francisco de Vitoria