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

I

Insel Gruppe AG, University Hospital Bern

Status

Not yet enrolling

Conditions

Multiple Sclerosis

Study type

Observational

Funder types

Other

Identifiers

NCT06221631
ethic number 2023-D0110
CIV-23-12-045014 (Other Identifier)
10001315 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Group 1: Healthy Controls
Description:
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
Description:
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)

Trial contacts and locations

1

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Central trial contact

Alejandro X. León Betancourt, Dr.med.; Piotr Radojewski, Dr.med.

Data sourced from clinicaltrials.gov

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