BrainAgeMS - a Comparative Study of Brain Aging in Healthy and Patients With Multiple Sclerosis
Recruiting · NCT06221631 · Observational (researchers observe without assigning treatment) · Lead sponsor: Insel Gruppe AG, University Hospital Bern
View the official record on ClinicalTrials.gov →What this trial is 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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Inselspital Bern - Bern, Canton of Bern, Switzerland