Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)

Launched by HOSPITAL CLINIC OF BARCELONA · Jan 19, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option called non-invasive vagus nerve stimulation for patients with Systemic Lupus Erythematosus (SLE), an autoimmune disorder that can cause various symptoms, including musculoskeletal pain. The aim is to understand how different settings of this stimulation can help improve symptoms while reducing any side effects. Researchers will be looking at various health markers and outcomes to find the most effective ways to tailor this treatment to individual patients.

To participate in this study, individuals must have a diagnosis of SLE and experience significant pain. They should also be stable on certain medications, like corticosteroids, for at least 28 days prior to joining. Participants will be closely monitored throughout the trial, and they may receive non-invasive stimulation treatments to see how well they work for managing their symptoms. It’s important to note that certain health conditions or recent treatments may exclude someone from joining the study, so interested individuals should discuss their specific situation with their healthcare provider.

Gender

ALL

Eligibility 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