Brain Aging - a Comparative Study in Healthy and Patients With Multiple Sclerosis as Model of a Chronic Neuroinflammatory Disorder (BrainAgeMS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Brain Age Gap in patients with MS
研究概览
简要总结
The purpose of this study is to investigate new quantitative MRI-sequences for assessment of age-specific data for the prediction of brain aging.
详细描述
After being informed about the study, healthy controls and patients with multiple sclerosis giving written informed consent will undergo blood examination (for determination of the biological age using the publicly available R-package algorithm BioAge), clinical examination (for motor, cognitive and psychological parameters) as well as an MRI-investigation with chemical exchange saturation transfer (CEST) and T1-relaxometry on a 7 Tesla MRI. Data from the healthy controls will be used to set up a normative brain age data set, that could be used for example to train a model for brain age prediction.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent signed by the subject
- •Group 1: Any healthy individual between 18 and 65 years of age
- •Group 2: Any individuals with any diagnosis of Multiple Sclerosis between 18 and 65 years of age and EDSS ≤6.0.
排除标准
- •Group 1 and 2: Any other neurological disease except primary headaches: insufficient language skills in German or French; pregnancy, lactation, any contraindication for MRI (active implants, passive ferromagnetic implants, passive non-ferromagnetic metallic implants >4cm in the region covered by the active RF coils, large tattoos inside a region covered by the active radiofrequency (RF) coils, claustrophobia or suspected/known non-compliance), smoking within the last 10 years prior recruitment, any other drug consumption except moderate alcohol intake (less than a standard drink containing 10 grams of alcohol per day) or use of medical cannabis, any previous head trauma (with known/suspected intracranial consequences), Body Mass Index (BMI) >30, and any other chronic progressive disease.
- •Specific Criteria for group 1: The calculated biological age (BioAge R Package algorithm) differs by > -8/+1 years from the chronological age. These patients will not be further invited for a study visit with clinical examination and MRI.
- •Specific Criteria for group 2: EDSS > 6.0 as this impacts physical testing; clinical relapse within the last 6 months
研究组 & 干预措施
Group 1: Healthy Controls
Healthy individuals with a predefined healthy lifestyle (s. inclusion/exclusion criteria), without any progressive disease or any neurological disorder (aside from primary headaches)
Group 2: Patients with Multiple Sclerosis
Patients with MS with a similar healthy lifestyle (s. inclusion/exclusion criteria), who are able to walk without more than one-sided walking aid (max. EDSS of 6 points), no relapse activity in the last 6 months, without any other progressive disease or other neurological disorder (aside from primary headaches)
结局指标
主要结局
Brain Age Gap in patients with MS
时间窗: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Difference between estimated brain age and (A) biological as well as (B) chronological age.
次要结局
- Relationship of brain age gaps with disease severity(Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.)
- Relationship of brain age gaps with gait speed(Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.)
- Relationship of brain age gaps with quality of life(Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.)
- Relationship of brain age gaps with depression symptoms(Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.)
- Relationship of brain age gaps with upper extremity function(Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.)
- Relationship of brain age gaps with sitting-to-raise time(Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.)
- Relationship of brain age gaps with fatigue(Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.)
- Relationship of brain age gaps with cognitive symptoms(Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.)
研究者
Alejandro León Betancourt
Medical Resident
Insel Gruppe AG, University Hospital Bern