NCT05704153Unknown不适用
Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of patients with Systemic Lupus Erythematosus with clinical and analytic change after non-invasive vagus nerve stimulation (nVNS) at different waveform parameters
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
30 hertz (Hz) Stimulation
Experimental
Group of patients treated via 30Hz transcutaneous electrical nerve stimulation
干预措施: Parasym 30Hz (Device)
1Hz Stimulation
Experimental
Group of patients treated via 1Hz transcutaneous electrical nerve stimulation
干预措施: Parasym 1Hz (Device)
Sham
Sham Comparator
Control group to be subjected to sham stimulation.
干预措施: Sham Intervention (Device)
结局指标
主要结局
Number of patients with Systemic Lupus Erythematosus with clinical and analytic change after non-invasive vagus nerve stimulation (nVNS) at different waveform parameters
时间窗: Visit 1(baseline, exploratory study, up to 30days prior to first nVNS)
We will develop an nVNS platform with an integrated nVNS decision support system, including nVNS and physiological wearable sensors, that will optimize nVNS waveform parameters to maximize the therapeutic effect while minimizing unwanted side effects. Therapeutic effect and side effects will be measured by clinical, neurophysiological and analytic tests as described in "secondary outcome measures".
次要结局
- Alpha interferon (IFNα)(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Numeric scale ranges (NRS)(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Lupus Patient-Reported Outcome (LupusPRO)(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Anti-dsDNA(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Tumoral necrosis factor (TNF), Interleukin (IL) -6, IL-10 and Il1B(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Patients' Global Assessment (PtGA)(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Visual Analog Scale (VAS)(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- High mobility group box 1 protein (HMGB1)(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- 28-joint count(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Physician's Global Assessment (PGA)(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- High-frequency power, low-frequency power(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- C-reactive protein(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Composite Autonomic Symptom Score (Compass-31)(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Cardiovagal evaluation. (Composite autonomic scoring scale)(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- C3, C4(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- EuroQol-5D (EQ-5D-5L),(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels and 1 month after nVNS.)
- Fatigue Severity Scale (FSS)(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Blood count(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Erythrocyte sedimentation rate(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Lupus Quality of Life (LupusQoL)(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Vasalva ratio(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- LF to HF power ratio(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- BILAG-2004(Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
- Sympathetic evaluation (Composite autonomic scoring scale)(Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels)
研究者
Judith Navarro, MD PhD
Consultant Neurologist
Hospital Clinic of Barcelona
研究点 (1)
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