Non-invasive vagus nerve stimulation for autoimmune diseases
Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)
This study is testing if a new type of nerve stimulation can help people with lupus feel better by finding the best way to use the treatment without causing side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Drugs / interventions | rituximab, cyclophosphamide, prednisone |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05704153 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the relationship between non-invasive vagus nerve stimulation waveform parameters and their therapeutic effects in patients with systemic lupus erythematosus. The study will analyze physiological signals, clinical biomarkers, and clinical outcomes to identify optimal stimulation parameters that enhance therapy benefits while minimizing side effects. Participants will receive different stimulation frequencies, including a sham intervention, to assess the effectiveness of the treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with systemic lupus erythematosus who experience significant musculoskeletal pain.
Not a fit: Patients who have recently undergone treatment with rituximab or cyclophosphamide may not benefit from this study due to potential alterations in biomarker results.
Why it matters
Potential benefit: If successful, this approach could provide a novel therapeutic option for managing symptoms of systemic lupus erythematosus and other autoimmune disorders.
How similar studies have performed: While the specific approach of non-invasive vagus nerve stimulation for autoimmune diseases is novel, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Systemic lupus erythematosus (SLE) (defined by the American College of Rheumatology- or SLICC criteria) * Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale * BILAG C on Musculoskeletal Domain of the BILAG 2004 * If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 28 days before baseline, * If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline * Able and willing to give written informed consent and comply with the requirements of the study protocol. Exclusion Criteria: * Treatment with rituximab within one year of baseline as it is related to lymphocyte depletion that could alter the result of the biomarker study (subjects with previous treatment with rituximab can enter study only with documentation of B cell repletion). * Treatment with cyclophosphamide within 2 months of baseline as it is related to lymphocyte depletion that could alter the result of the biomarker study. * Expectation to increase steroids and/or immunosuppressive treatment. * Anti-phospholipid syndrome. * Fibromyalgia (fibromyalgia will be defined as a score \> 13 on the Fibromyalgia Symptom Scale), chronic fatigue syndrome. * Treatment with an anti-cholinergic or sympathicomimetic medication, including over the counter medications. * Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators. * Joint replacement within 60 days prior to study enrolment or planned within the course of the study. * Any planned surgical procedure requiring general anaesthesia within the course of the study. * Intra-articular cortisone injections within 28 days of the start of study. * Chronic inflammatory disorders apart from SLE affecting the joints. * Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time. * Active infection including hepatitis B, hepatitis C or HIV at baseline due to high prevalence of neuropathy. * Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention. * Pregnancy or lactation. * Haemoglobin below 9.0 gm/dL (by the most recent CBC) as anaemia is related to no- neurogenic orthostatic hypotension and increases cardiovascular symptoms in COMPASS 31 scale * Comorbid disease that may require administration of corticosteroid use. * Inability to comply with study and follow-up procedures. * Known cardiac arrhythmia, severe cardiac disease or neurodegenerative disease. * Known or confirmed at baseline screening peripheral or autonomic nervous system involvement, including LES-related, toxic polyneuropathies, metabolic neuropathies (including diabetes), etc. * Previous experience with vagus nerve stimulation devices
Where this trial is running
Barcelona
- Hospital Clinic — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Judith Navarro, MD
- Email: JNAVARR1@clinic.cat
- Phone: 0034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.