Comparative study of brain aging in healthy individuals and those with multiple sclerosis

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

This study is testing new MRI techniques to see how brain aging differs between healthy people and those with multiple sclerosis.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (other)
• Locations: 1 site (Bern, Canton of Bern)
• Trial ID: NCT06221631 on ClinicalTrials.gov

What this trial studies

This study investigates new quantitative MRI sequences to assess age-specific data for predicting brain aging in both healthy individuals and patients with multiple sclerosis. Participants will undergo blood examinations to determine biological age, clinical evaluations for various parameters, and advanced MRI scans using chemical exchange saturation transfer and T1-relaxometry on a 7 Tesla MRI. The data collected from healthy controls will help establish a normative brain age dataset, which could be utilized for training predictive models for brain aging.

Who should consider this trial

Good fit: Ideal candidates include healthy individuals and patients diagnosed with multiple sclerosis aged 18 to 65 with an EDSS score of 6.0 or lower.

Not a fit: Patients with other neurological diseases or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of brain aging in multiple sclerosis and improve predictive models for patient outcomes.

How similar studies have performed: While studies on brain aging and multiple sclerosis exist, this approach utilizing advanced MRI techniques and biological age assessment is relatively novel.

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

Where this trial is running

Bern, Canton of Bern

• Inselspital Bern — Bern, Canton of Bern, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Robert Hoepner, PD Dr.med. — Head of the MS outpatient clinic
• Study coordinator: Alejandro X. León Betancourt, Dr.med.

Conditions: Multiple Sclerosis, Brain Aging, Neurodegeneration, Quantitative MRI