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Completed

NCT Number: NCT07646470

Effects of Chronic Non-invasive Vagus Nerve Stimulation in an Asplenic Individual Suffering From Rheumatoid Arthritis

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

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Key information

Conditions

Rheumatoid Arthritis (RA Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

OsteoFlow Health Clinic

Moncton, New Brunswick, E1C 5N3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed RA
  • splenectomy

Exclusion criteria

Pharmaceutical treatment as:

  • disease-modifying antirheumatic drugs (DMARDs)
  • Biologics
  • Jak inhibitors

Treatment and study plan

Trans-auricular vagus nerve stimulation

Device

24 months self-administrated trans-auricular vagus nerve stimulation in an asplenic patient.

Primary outcomes

  1. Change in the Simple Disease Activity Index (SDAI) for Rheumatoid Arthritis

    Time frame: 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 outcomes

  1. Change in the sympathovagal balance

    Time frame: 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

Other outcomes

  1. Change in the Neuro-immunological (NIM) Index

    Time frame: From enrollment to the end of treatment at 24-month

    the neuro-immunological index express the effect of vagal modulation on inflammation and is the ratio of RMSSD / CRP

Sponsors and collaborators

Lead sponsor

Osteoflow Health Clinic

Other

Registry information

Official study title

Effects of Non-Invasive Vagus Nerve Stimulation on Rheumatoid Arthritis: A Longitudinal Prospective Case Study.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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