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

NCT07646470 | Completed

• 1 other identifier: PI-KHA-RA20
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis (RA

Keywords

non-invasive vagus nerve stimulation; rheumatoid athritis; heart rate variability; splenectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in the sympathovagal balance

  From enrollment to the end of treatment at 24-month

Other Outcomes (1)

• Change in the Neuro-immunological (NIM) Index

  From enrollment to the end of treatment at 24-month

Study Arms (1)

n-of-1

EXPERIMENTAL

Device: Trans-auricular vagus nerve stimulation

Interventions

Trans-auricular vagus nerve stimulation DEVICE

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

n-of-1

Eligibility Criteria

• Gender Eligibility Details: Eligibility to participate in the study is limited to specific gender that aligns with the sex they assigned at birth.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed RA
• splenectomy

You may not qualify if:

• Pharmaceutical treatment as:
• disease-modifying antirheumatic drugs (DMARDs)
• Biologics
• Jak inhibitors

Sponsors & Collaborators

• Osteoflow Health Clinic: lead

Study Sites (1)

OsteoFlow Health Clinic

Moncton, New Brunswick, E1C 5N3, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: n-of-1 longitudinal study

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 12, 2026
• Study Start: January 30, 2020
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

CA (1)