NCT04635033已完成不适用
Safety and Tolerance of an Intermittent Intervention in MS Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Lake Louise Score (LLS)
研究概览
简要总结
This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years
- •confirmed MS (all types of MS)
- •ability to come to the outpatient clinic 2-3x/week for 3 months
- •EDSS ≤ 6.5
- •inconspicuous medical examination
- •inconspicuous ECG
排除标准
- •relapse in the last 3 months
- •EDSS progression in the last 6 months
- •pregnancy
- •contraindication for MRI
- •severe heart disease
- •severe asthma, COPD
- •severe cognitive deficits
- •chronic headache
- •renal insufficiency
- •anaemia (Hb < 10 g/dl)
- •insulin-dependent diabetes mellitus
- •severe vascular stenosis
- •former episodes of severe high mountain sickness
结局指标
主要结局
Lake Louise Score (LLS)
时间窗: Change of mean LLS before vs. after 1 hour vs. after 2 hours of each session
Tolerance by measuring the development of acute mountain sickness during the sessions Score 3 to 5 = mild AMS Score 6 or more = severe AMS
次要结局
- Timed 25-Foot Walk (T25-FW)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- MRI Lesions(Baseline, at the end of the intervention (after 3 months))
- Blood pressure(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Erythropoetin(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- 6 minute walking test (6MWT)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Blood count(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Liver enzymes(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- NFL(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Expanded Disability Status Scale (EDSS)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Symbol Digit Modalities Test (SDMT)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Brief Visuospatial Memory Test-Revised (BVMT-R)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Brain atrophy(Baseline, at the end of the intervention (after 3 months))
- Immune cell subsets(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Kidney enzyme(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- 9-Hole-Peg-Test (9 HPT)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Frenchay Activities Index (FAI)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Beck Depression Inventory (BDI)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Verbal learning and memory test (VLMT)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Fatigue Scale Motor Cognition (FSMC)(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
- Heart rate(During every session (2hours/session))
- Oxygen saturation(During every session (2hours/session))
- Blood sugar(Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months))
研究者
Prof. Dr. med. Christoph Heesen
Principal Investigator
Universitätsklinikum Hamburg-Eppendorf
研究点 (1)
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