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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-27

Study Completion Date

2028-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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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 \> +/- 3 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes