NCT05315739已完成不适用
Vagus Nerve Stimulation as a Novel Treatment for Systemic Lupus Erythematous: A Double Blinded Randomized Controlled Trail
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Fatigue (changes during period 1 and 2)
研究概览
简要总结
This trial uses a double blinded, randomized 1:1 (active:sham) placebo controlled, parallel group design, investigating the effects of transcutaneous vagus nerve stimulation (tVNS) in patients with systemic lupus erythematosus (SLE).
The main objective is to evaluate whether adjuvant treatment with tVNS in SLE patients with signs of autonomic dysfunction and fatigue improves patient perceived levels of fatigue. Secondary outcomes include tVNS induced changes to: patient reported outcomes, autonomic nervous system function, SLE disease activity, immunologic profile, tolerability of pain and organ (cardiac, vascular and kidney) functions.
Participants are randomized to received either active non-invasive transcutaneous vagus nerve stimulation (tVNS) or inactive sham stimulation. The study period is divided in two periods. The first period investigates the effects of short-term, high-intensity tVNS treatment. The second phase investigates the effects of long-term, middle-intensity tVNS treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Reading and understanding Danish.
- •SLE diagnosis based on SLE disease classification criteria for at least 1 year.
- •Stable disease and medication the past 28 days as defined by:
- •No change in disease modifying antirheumatic drugs or biological therapy,
- •Receiving maximally 10 mg prednisone daily.
- •Having signs of fatigue, as assessed by scoring ≤ 40 in the FACIT-Fatigue questionnaire.
- •Having signs of autonomic dysfunction, as assessed by scoring one or more of:
- •VAGUS score ≥1
- •SUDOSCAN score < 50µS for hands or < 70µS for feet
- •COMPASS-31 score > 12
- •Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
- •Sign the dated informed consent documents
排除标准
- •Significant cardiovascular disease, including congenital cardiac disease, congestive heart failure, known severe coronary artery disease, or recent myocardial infarction (within 5 years), as assessed by a physician at the screening.
- •Blood pressure < 100/60 or > 160/105
- •Clinically significant bradycardia or tachycardia
- •History of abnormal baseline ECG, prolonged QT interval or arrhythmia
- •Previous surgery on the vagus nerve or abnormal cervical anatomy
- •Implanted or portable electro-mechanical medical devices, e.g. pacemaker, defibrillator, cochlear implant and infusion pump
- •Metallic device such as a stent, bone plate or bone screw implanted at or near the neck
- •Receiving active laser treatment for proliferative retinopathy
- •Active cancer or cancer in remission
- •History of brain tumor, aneurysm, bleed, head trauma, clinically significant syncope or seizures
- •Any clinical abnormalities that, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
- •Participation in other clinical trials less than three months prior to inclusion, unless such a participation is judged to have no influence on the recordings
- •Female pregnancy (positive urine-HCG), ongoing lactation or intended pregnancy during the study period.
- •A pregnancy test is conducted at first and last visit to ensure that fertile female patients are not pregnant during the study period.
- •Further, the investigator ensures that fertile female patients use a safe contraception method during the study and for at least 15 hours after termination of the study period. Safe contraception: The combined oral contraceptive pill; intra uterine device; gestagen injection; subdermal implantation; hormone vaginal ring; and transdermal plaster.
- •Male patients who intend to father a child during the course of the study
研究组 & 干预措施
Active treatment
Active Comparator
Non-invasive transcutaneous vagus nerve stimulation applied by the gammaCore device (electroCore)
干预措施: Non-invasive transcutaneous vagus nerve stimulation (tVNS) (Device)
Sham treatment
Sham Comparator
Inactive sham vagus nerve stimulation applied by the gammaCore sham device (electroCore)
干预措施: Sham vagus nerve stimulation (Device)
结局指标
主要结局
Fatigue (changes during period 1 and 2)
时间窗: During period 1: At baseline, daily (day 2-6) until- and at follow-up (day 7). During period 2: At baseline, at day 7-visit, weekly (week 3-7) until- and at follow-up (week 8).
The FACIT-Fatigue Scale is a short, 13-item, tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point scale for each item. The theoretical maximum value is 52 (maximal fatigue) and minimum 0 (no fatigue).
次要结局
- Questionnaire on autonomic symptoms: Composite Autonomic Symptoms Score 31 (COMPASS-31)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Questionnaire on SLE disease activity: Patient Global Assessment (PtGA)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, weekly (week 3-7) until- and at follow-up (week 8).)
- Questionnaire on SLE disease activity: Systemic Lupus Activity Questionnaire (SLAQ)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, and at follow-up (week 8).)
- Questionnaire on quality of life: Short form-12 (SF-12)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, and at follow-up (week 8).)
- Questionnaire on pain: Visual analog rating scale (VAS)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, weekly (week 3-7) until- and at follow-up (week 8).)
- SLE disease activity: SLE Disease Activity Index 2000 (SLEDAI-2K)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- SLE disease activity: SLEDAI Responder Index 50% (SRI-50)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- SLE disease activity: SLE Disease Activity Score (SLE-DAS)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- SLE disease activity: Physician Global Assessment (PGA)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- SLE disease activity: Painful and swollen joints(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Autonomic function: Resting heart rate variability (HRV)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Autonomic function: Resting Cardiac Vagal Tone (CVT)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Autonomic function: Cardiovascular autonomic reflex tests - heart rate response(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Autonomic function: Cardiovascular autonomic reflex tests - blood pressure response(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Autonomic function: Continuous heart rate and HRV monitoring(During period 1: From baseline to follow-up (day 7). During period 2: From baseline to day 7-visit.)
- Autonomic function: Sweat secretion(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Pain tolerability: Cold pressor test(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Pain tolerability: Conditioned pain modulation (CMP)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Cardiac function(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Vascular function: Microvascular function(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- SLE routine status(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- SLE inflammatory status - Multiplex plasma cytokine analysis(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- SLE inflammatory status - Interferon-regulated gene expression(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- SLE inflammatory status - Functional immune cell stimulation(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Kidney function(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Metabolic control(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- SLE inflammatory status - Immune cell population distribution in whole blood(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
- Medication usage(Medication status is reported at all visits (period 1: baseline and follow-up (day 7); period 2: baseline, day 7 and follow-up (week 8)) and three months after completing the study)
研究者
Søren Jacobsen
Professor, MD, DMSc
Rigshospitalet, Denmark
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Vagus Nerve Stimulation to Treat Moderate Traumatic Brain InjuryTraumatic Brain InjuryAcute Brain InjuriesNCT02974959CentraCare14
招募中
不适用
nVNS for the Prevention and Treatment of Primary HeadacheMigraine in AdolescencePrimary HeadacheMigraine in ChildrenTension HeadacheCluster HeadacheNCT06277063Nanfang Hospital, Southern Medical University15
已完成
不适用
Non-Invasive Neurostimulation for the Prevention of Chronic MigraineChronic MigraineNCT01667250ElectroCore INC59
撤回
不适用
Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore Device for the Relief of EIBAsthmaNCT01923272ElectroCore INC
已完成
不适用
Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid HemorrhageSubarachnoid Hemorrhage, AneurysmalNCT04126408Northwell Health40