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

NCT06221631 | Recruiting

• 3 other identifiers: ethic number 2023-D011010001315CIV-23-12-045014
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Brain Aging; Multiple Sclerosis; Neurodegeneration; Quantitative MRI

Outcome Measures

Primary Outcomes (1)

• Brain Age Gap in patients with MS

  Difference between estimated brain age and (A) biological as well as (B) chronological age.

  Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

Secondary Outcomes (8)

• Relationship of brain age gaps with disease severity

  Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

• Relationship of brain age gaps with gait speed

  Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

• Relationship of brain age gaps with upper extremity function

  Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

• Relationship of brain age gaps with sitting-to-raise time

  Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

• Relationship of brain age gaps with cognitive symptoms

  Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.

Study Arms (2)

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)

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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group 1: recruitment from the general population through advertisement Group 2: recruitment primarily from the outpatient MS consultation in Inselspital

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Schweizerische Multiple Sklerose Gesellschaft: collaborator
• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Related Publications (3)

• 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: 10.1002/mrm.29540. Epub 2022 Dec 7.

  PMID: 36478417 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Multiple Sclerosis; Nerve Degeneration

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Hoepner, PD Dr.med.

  Head of the MS outpatient clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro X. León Betancourt, Dr.med.

CONTACT

+41316326093; alejandro.betancourt@insel.ch

Piotr Radojewski, Dr.med.

CONTACT

+41316326093; piotr.radojewski@insel.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Resident

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 24, 2024
• Study Start: August 27, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 9 months and ending 48 months after publication
• Access Criteria: Encoded data will be provided only to investigators who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to brainage@ikmail.com. To gain access, data requestors will need to sign a data access agreement.

Locations

CH (1)