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

Hospital Clinic of Barcelona

Status: Enrolling

Conditions: Autoimmune Disorder; Vagus Nerve Autonomic Disorder; Systemic Lupus Erythematosus

Treatments: Device: Sham Intervention; Device: Parasym 30Hz; Device: Parasym 1Hz

Study type: Interventional

Funder types: Other

Identifiers

NCT05704153

PID2020-117171RA-I00-1A

Details and patient eligibility

About

The overall goal of this clinical trial is to evaluate the causality relationship between the non vagus nerve stimulation waveform parameters and the therapeutic effect. Thus, unlocking a pathway to optimize parameters that maximize the benefits of therapy and minimize unwanted side effects. The experimental design includes the analysis of physiological signals, clinical biomarkers of disease, and clinical outcomes to determine the most effective measures for the monitoring, optimization, and personalization of non vagus nerve stimulation in systemic lupus erythematosus disease.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 3 patient groups

Sham

Sham Comparator group

Description:

Control group to be subjected to sham stimulation.

Treatment:

Device: Sham Intervention

30 hertz (Hz) Stimulation

Experimental group

Description:

Group of patients treated via 30Hz transcutaneous electrical nerve stimulation

Treatment:

Device: Parasym 30Hz

1Hz Stimulation

Experimental group

Description:

Group of patients treated via 1Hz transcutaneous electrical nerve stimulation

Treatment:

Device: Parasym 1Hz