Rheumatoid Arthritis (RANCT07646470
Effects of Chronic Non-invasive Vagus Nerve Stimulation in an Asplenic Individual Suffering From Rheumatoid Arthritis
A study testing Trans-auricular vagus nerve stimulation in people with Rheumatoid Arthritis (RA, run by Osteoflow Health Clinic at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Rheumatoid Arthritis (RA
- What is being tested?
- Trans-auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2020to 4 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed RA
- splenectomy
Who cannot join
- Pharmaceutical treatment as:
- disease-modifying antirheumatic drugs (DMARDs)
- Biologics
- Jak inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Non-Invasive Vagus Nerve Stimulation on Rheumatoid Arthritis: A Longitudinal Prospective Case Study.
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?
Read more
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
Read the 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.
- Conditions
- Rheumatoid Arthritis (RA
- Being tested
- Trans-auricular vagus nerve stimulation
- Keywords
- non-invasive vagus nerve stimulation, rheumatoid athritis, heart rate variability, splenectomy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-auricular vagus nerve stimulationDevice
24 months self-administrated trans-auricular vagus nerve stimulation in an asplenic patient.
| Study group | Role | What they receive |
|---|---|---|
| n-of-1 | Experimental | Not described Receives: Device: Trans-auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to the end of treatment at 24 months
Secondary outcomes (1)
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
Measured: From enrollment to the end of treatment at 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start30 Jan 2020
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- n-of-1 longitudinal study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osteoflow Health Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal JD Grolaux, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646470
- Sponsor's protocol ID
- PI-KHA-RA20
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-Invasive Vagus Nerve Stimulation on Rheumatoid Arthritis: A Longitudinal Prospective Case Study.
- ClinicalTrials.gov ID
- NCT07646470
- Acronym / sponsor ID
- PI-KHA-RA20
- Conditions
- Rheumatoid Arthritis (RA
- Keywords
- non-invasive vagus nerve stimulation, rheumatoid athritis, heart rate variability, splenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Osteoflow Health ClinicUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- n-of-1 longitudinal study
| Arm | Type | Receives |
|---|---|---|
| n-of-1 | Experimental | Device: Trans-auricular vagus nerve stimulation |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed RA
- splenectomy
Key exclusion criteria (4 listed)
- disease-modifying antirheumatic drugs (DMARDs)
- Biologics
- Jak inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-auricular vagus nerve stimulation24 months self-administrated trans-auricular vagus nerve stimulation in an asplenic patient. | Device | n-of-1 |
Primary outcome
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)
1 secondary outcome
Change in the sympathovagal balance
Time frame: From enrollment to the end of treatment at 24-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-auricular vagus nerve stimulation in people with Rheumatoid Arthritis (RA, run by Osteoflow Health Clinic at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Simple Disease Activity Index (SDAI) for Rheumatoid Arthritis (time frame: From enrollment to the end of treatment at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.