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

Multiple Sclerosis Clinical Trial

— BrainAgeMS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06221631
• Other study ID #: ethic number 2023-D0110
• Secondary ID: 10001315CIV-23-1
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: March 2028

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Alejandro X. León Betancourt, Dr.med.
• Phone: +41316326093
• Email: alejandro.betancourt[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Switzerland	Inselspital Bern	Bern

Sponsors (3)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	Schweizerische Multiple Sklerose Gesellschaft, University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relationship of brain age gaps with disease severity	Relationship of brain age gaps with disease severity as measured by the expanded disability and severity scale (EDSS; min.-max. according to eligibility criteria: 0-6 points, with a higher score meaning a higher degree of disease severity)	Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Secondary	Relationship of brain age gaps with gait speed	Relationship of brain age gaps with gait speed as measured by the 25-foot walking test	Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Secondary	Relationship of brain age gaps with upper extremity function	Relationship of brain age gaps with upper extremity function as measured by the 9-hole Peg Test	Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Secondary	Relationship of brain age gaps with sitting-to-raise time	Relationship of brain age gaps with a raising test using the sitting-to-raise time	Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Secondary	Relationship of brain age gaps with cognitive symptoms	Relationship of brain age gaps with cognitive (brief international cognitive assessment in multiple sclerosis (BICAMS))	Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Secondary	Relationship of brain age gaps with depression symptoms	Relationship of brain age gaps with depression symptoms as assessed with the brief depression inventory (BDI)	Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Secondary	Relationship of brain age gaps with fatigue	Relationship of brain age gaps with fatigue as assessed with the fatigue severity score (FSS)	Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Secondary	Relationship of brain age gaps with quality of life	Relationship of brain age gaps with experienced quality of life as assessed with the Multiple Sclerosis Impact Scale (MSIS)-29	Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.