Multiple SclerosisBrainAgeMSNCT06221631
BrainAgeMS - a Comparative Study of Brain Aging in Healthy and Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Aug 2024to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: recruitment from the general population through advertisement Group 2: recruitment primarily from the outpatient MS consultation in Inselspital
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital Bern
Bern, Canton of Bern, 3010
Alejandro X. León Betancourt, Dr.med., +41 31 632 60 93, alejandro.betancourt@insel.ch
Alejandro X. León Betancourt, Dr.med.
About this study
Official title: Brain Aging - a Comparative Study in Healthy and Patients With Multiple Sclerosis as Model of a Chronic Neuroinflammatory Disorder (BrainAgeMS)
The purpose of this study is to investigate new quantitative MRI-sequences for assessment of age-specific data for the prediction of brain aging.
Read the detailed 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Brain Aging, Multiple Sclerosis, Neurodegeneration, Quantitative MRI
- Medical subject headings
- Multiple Sclerosis, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Age Gap in patients with MS
Difference between estimated brain age and (A) biological as well as (B) chronological age.
Measured: 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
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)
Measured: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Relationship of brain age gaps with gait speed
Relationship of brain age gaps with gait speed as measured by the 25-foot walking test
Measured: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
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
Measured: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
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
Measured: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Relationship of brain age gaps with cognitive symptoms
Relationship of brain age gaps with cognitive (brief international cognitive assessment in multiple sclerosis (BICAMS))
Measured: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Relationship of brain age gaps with depression symptoms
Relationship of brain age gaps with depression symptoms as assessed with the brief depression inventory (BDI)
Measured: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Relationship of brain age gaps with fatigue
Relationship of brain age gaps with fatigue as assessed with the fatigue severity score (FSS)
Measured: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
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
Measured: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start27 Aug 2024
- Primary completionMar 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Schweizerische Multiple Sklerose Gesellschaft, University of Bern
- Responsible party
- Principal investigator, Alejandro León Betancourt, Insel Gruppe AG, University Hospital Bern
- Investigators
- Robert Hoepner, PD Dr.med., Principal investigator, Head of the MS outpatient clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221631
- Sponsor's protocol ID
- ethic number 2023-D0110
- Other IDs
- 10001315, CIV-23-12-045014
- Acronym
- BrainAgeMS
- Status last verified
- Feb 2026
- First submitted
- 3 Jan 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participants data that underlie results in a publication, after deidentification
Publications
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.
PubMed 36478417Mennecke 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.
PubMed 35194865Kwon 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.
PubMed 34725754Navarrete S, Capiglioni M, Marti S, Pirpamer L, McKinley R, Hoepner R, Leon Betancourt A, Radojewski P. BrainAgeMS: protocol for a prospective comparative study of brain aging in healthy adults and people with multiple sclerosis. Front Neurol. 2026 Aug 11;17:1899641. doi: 10.3389/fneur.2026.1899641. eCollection 2026.
PubMed 42643735
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Aging - a Comparative Study in Healthy and Patients With Multiple Sclerosis as Model of a Chronic Neuroinflammatory Disorder (BrainAgeMS)
- ClinicalTrials.gov ID
- NCT06221631
- Acronym / sponsor ID
- BrainAgeMS / ethic number 2023-D0110
- Conditions
- Multiple Sclerosis
- Keywords
- Brain Aging, Multiple Sclerosis, Neurodegeneration, Quantitative MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Schweizerische Multiple Sklerose Gesellschaft, University of Bern
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate new quantitative MRI-sequences for assessment of age-specific data for the prediction of brain aging.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: recruitment from the general population through advertisement Group 2: recruitment primarily from the outpatient MS consultation in Inselspital
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain Age Gap in patients with MS
Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Difference between estimated brain age and (A) biological as well as (B) chronological age.
8 secondary outcomes
Relationship of brain age gaps with disease severity
Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Relationship of brain age gaps with gait speed
Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Relationship of brain age gaps with upper extremity function
Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Relationship of brain age gaps with sitting-to-raise time
Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Relationship of brain age gaps with cognitive symptoms
Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Relationship of brain age gaps with depression symptoms
Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Relationship of brain age gaps with fatigue
Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Relationship of brain age gaps with quality of life
Time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 36478417Piredda 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.
- Background: PubMed 35194865Mennecke 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.
- Background: PubMed 34725754Kwon 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.
- Derived from this study: PubMed 42643735Navarrete S, Capiglioni M, Marti S, Pirpamer L, McKinley R, Hoepner R, Leon Betancourt A, Radojewski P. BrainAgeMS: protocol for a prospective comparative study of brain aging in healthy adults and people with multiple sclerosis. Front Neurol. 2026 Aug 11;17:1899641. doi: 10.3389/fneur.2026.1899641. eCollection 2026.
- Individual participant dataSharing planned: Yes. Individual participants data that underlie results in a publication, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Hoepner, PD Dr.med. principal investigator
Head of the MS outpatient clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandro X. León Betancourt, Dr.med. (+41316326093, alejandro.betancourt@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Age Gap in patients with MS (time frame: Up to 2 months after recruitment or finalization of MRI-visit, whichever came first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06221631, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.