BrainAgeMS - a Comparative Study of Brain Aging in Healthy and Patients With Multiple Sclerosis

Официальное название

Brain Aging - a Comparative Study in Healthy and Patients With Multiple Sclerosis as Model of a Chronic Neuroinflammatory Disorder (BrainAgeMS)

Обзор

The purpose of this study is to investigate new quantitative MRI-sequences for assessment of age-specific data for the prediction of brain aging.

Подробное описание

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.

Первичные конечные точки

• Brain Age Gap in patients with MS [Срок оценки: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]

Вторичные конечные точки (8)

• Relationship of brain age gaps with disease severity [Срок оценки: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
• Relationship of brain age gaps with gait speed [Срок оценки: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
• Relationship of brain age gaps with upper extremity function [Срок оценки: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
• Relationship of brain age gaps with sitting-to-raise time [Срок оценки: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
• Relationship of brain age gaps with cognitive symptoms [Срок оценки: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
• Relationship of brain age gaps with depression symptoms [Срок оценки: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
• Relationship of brain age gaps with fatigue [Срок оценки: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
• Relationship of brain age gaps with quality of life [Срок оценки: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Швейцария · 1 центр

• Inselspital Bern — Bern

Публикации

• Piredda GF, Caneschi S, Hilbert T, Bonanno G, Joseph A, Egger K, Peter J, Kloppel S, Jehli E, Grieder M, Slotboom J, Seiffge D, Goeldlin M, Hoepner R, Willems T, Vulliemoz S, Seeck M, Venkategowda PB, Corredor Jerez RA, Marechal B, Thiran JP, Wiest R, Kober T, Radojewski P. Submillimeter T1 atlas for subject-specific abnormality detection at 7T. Magn Reson Med. 2023 Apr;89(4):1601-1616. doi: 10.10 PMID 36478417
• Mennecke A, Khakzar KM, German A, Herz K, Fabian MS, Liebert A, Blumcke I, Kasper BS, Nagel AM, Laun FB, Schmidt M, Winkler J, Dorfler A, Zaiss M. 7 tricks for 7 T CEST: Improving the reproducibility of multipool evaluation provides insights into the effects of age and the early stages of Parkinson's disease. NMR Biomed. 2023 Jun;36(6):e4717. doi: 10.1002/nbm.4717. Epub 2022 Mar 17. PMID 35194865
• Kwon D, Belsky DW. A toolkit for quantification of biological age from blood chemistry and organ function test data: BioAge. Geroscience. 2021 Dec;43(6):2795-2808. doi: 10.1007/s11357-021-00480-5. Epub 2021 Nov 2. PMID 34725754

Идентификаторы

NCT: NCT06221631 · ethic number 2023-D0110 · 10001315 · CIV-23-12-045014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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