NCT06611280招募中不适用
Deuterium Metabolic Imaging in People with Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- lactate to glx ratio
研究概览
简要总结
The goal of this case-control study is to investigate glucose brain metabolism in people with multiple sclerosis and age- and sex-matched healthy controls. The main questions it aims to answer are:
- How does brain glucose metabolism in people with multiple sclerosis compare to age- and sex-matched healthy controls?
- How is the brain glucose metabolism of people with multiple sclerosis associated with disease severity?
Participants will come in for testing lasting approximately three hours and undergo deuterium metabolic imaging, physical function test, cognitive function test, and answer survey.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-60 years.
- •Definite Relapsing remitting multiple sclerosis diagnosis according to the most recent diagnostic criteria
排除标准
- •Contraindications for MRI:
- •Pacemaker, neurostimulator or cholera implant. Metal foreign bodies such as fragments and irremovable piercings. Unsafe medical implants (safety of heart valves, hips and the like must be confirmed).
- •Claustrophobia. Largest circumference including arms > 160 cm
- •Pregnancy
- •Competing neurological, psychiatric, or systemic diseases including diabetes (except prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed).
- •Participating in other clinical trials with investigational medical products or drugs.
结局指标
主要结局
lactate to glx ratio
时间窗: 2 hours from enrollment to end of assessment
Brain deuterium metabolic imaging determined lactate to glx ratio
次要结局
- Six-minute walk test(3 hours from enrollment to end of assessment)
- 25 meter walk test(3 hours from enrollment to end of assessment)
- Six-spot-step-test(3 hours from enrollment to end of assessment)
- Handgrip strength(3 hours from enrollment to end of assessment)
- 5-sit-to-stand(3 hours from enrollment to end of assessment)
- Processing speed - Selective reminding test(3 hours from enrollment to end of assessment)
- Memory function - Symbol digit modality test(3 hours from enrollment to end of assessment)
- Glukose level(3 hours from enrollment to end of assessment)
- Lactat level(3 hours from enrollment to end of assessment)
- Glucose uptake(2 hours from enrollment to end of assessment)
- glucose to glx ratio(2 hours from enrollment to end of assessment)
- Clinical information on multiple sclerosis - Disease modifying treatment(7 days from enrollment to end of assessment)
- Clinical information on multiple sclerosis - Time since diagnosis(7 days from enrollment to end of assessment)
- Modified Fatigue Impact Scale(7 days from enrollment to end of assessment)
- Clinical information on multiple sclerosis - Expanded disability status score(7 days from enrollment to end of assessment)
- Multiple Sclerosis Impact Scale(7 days from enrollment to end of assessment)
研究者
研究点 (1)
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