BrainAgeMS - a Comparative Study of Brain Aging in Healthy and Patients With Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Brain Aging - a Comparative Study in Healthy and Patients With Multiple Sclerosis as Model of a Chronic Neuroinflammatory Disorder (BrainAgeMS)
Overview
The purpose of this study is to investigate new quantitative MRI-sequences for assessment of age-specific data for the prediction of brain aging.
Detailed description
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.
Primary outcome measures
- Brain Age Gap in patients with MS [Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
Secondary outcome measures (8)
- Relationship of brain age gaps with disease severity [Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
- Relationship of brain age gaps with gait speed [Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
- Relationship of brain age gaps with upper extremity function [Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
- Relationship of brain age gaps with sitting-to-raise time [Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
- Relationship of brain age gaps with cognitive symptoms [Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
- Relationship of brain age gaps with depression symptoms [Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
- Relationship of brain age gaps with fatigue [Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
- Relationship of brain age gaps with quality of life [Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Switzerland · 1 center
- Inselspital Bern — Bern
Publications
- 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
Identifiers
NCT: NCT06221631 · ethic number 2023-D0110 · 10001315 · CIV-23-12-045014