Multiple SclerosisPROCLAIMNCT07032246
Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study
A study testing quantitative brain MRI (icobrain mr) in people with Multiple Sclerosis and Radiologically Isolated Syndrome, run by icometrix at 6 sites in 3 countries.
Trial summary
The goal of the PROCLAIM study is to assess the effectiveness of quantitative brain MRI, as measured by icobrain mr, on the detection of disease activity in multiple sclerosis, including the identification of smouldering disease, and the downstream effects on clinical decision making and patient outcomes in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Radiologically Isolated Syndrome, Clinically Isolated Syndrome
- What is being tested?
- quantitative brain MRI (icobrain mr)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 9 Oct 2025to 30 Nov 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to independently understand, evaluate and sign the informed consent form.
- Able to comply with the study protocol, including having a mobile device capable of running the icompanion app.
- Have a definite diagnosis of MS, confirmed as per revised McDonald 2017 criteria (treated or untreated) and/or a diagnosis of RIS/CIS (following the revised McDonald criteria presented during ECTRIMS 2024)
- Patients early in the disease course of RRMS (CIS/RIS, RRMS with disease duration < 7 years), patients with initial diagnosis of relapsing MS and disease duration 12-18 years (prone to convert to SPMS).
- Clinical and brain MRI data available at least one year prior to the study
- Age >= 18 years
Who cannot join
- Unable or unwilling to understand, evaluate and sign the informed consent form.
- Any contraindications for undergoing an MRI.
- Currently involved in another interventional study.
- Currently pregnant or planning a pregnancy in the coming 2 years.
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the study.
- Retrospective MRI not meeting requirements: at least, 3D T1-weighted images and fluid-attenuated inversion recovery (FLAIR) images (3D, or 2D with maximal slice thickness of 3mm).
- Patients with confirmed diagnosis of PPMS.
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Germany3 sites
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 131256
Katholisches Klinikum Bochum - St. Joseph-Hospital
Bochum, North Rhine-Westphalia, 44791
Technische Universität Dresden
Dresden, Saxony, 01062
About this study
The goal of the PROCLAIM study is to assess the effectiveness of quantitative brain MRI, as measured by icobrain mr, on the detection of disease activity in multiple sclerosis, including the identification of smouldering disease, and the downstream effects on clinical decision making and patient outcomes in a real-world setting.
The study will compare an intervention arm implementing quantitative brain MRI (using the CE-marked medical device software icobrain mr) as part of Standard of Care, and a control arm implementing Standard of Care without quantitative brain MRI.
Read the detailed description
PROCLAIM (Clinical Impact through AI-assisted MS care: a prospective multi-centre study) is a prospective multi-country multi-site comparative effectiveness study conducted within the scope of the EU-funded research project "Clinical impact through AI-assisted MS Care" (CLAIMS). Quantitative brain MRI will be implemented in this study based on the icobrain mr medical device. icobrain mr is an AI software solution for brain MRI analysis in multiple sclerosis that provides quantitative measurements on disease activity and progression. icobrain mr is CE-marked as a medical device software Class IIa and will be used in PROCLAIM according to its intended use. The study does not involve procedures additional to those performed under the normal conditions of use of the device, nor any other invasive or burdensome procedures.
The study will assess the impact of using quantitative brain MRI, as measured by icobrain mr, on the quality of care. In particular, the study will evaluate the impact on detecting disease activity in MS, as well as on clinical decision-making and clinical outcomes in routine clinical practice for people with MS (pwMS). The study will target both the inflammatory and smouldering components of the disease using assessments already used in daily clinical routine. Exploratory analyses will focus on the relation to other biomarkers used in clinical routine of the participating sites (optic coherence tomography (OCT), evoked potentials (EPs)), as well as patient reported outcomes and passive monitoring measurements (sleep duration, step count and environmental temperature) collected via the icompanion patient app, in conjunction with clinical and radiological parameters.
- Being tested
- quantitative brain MRI (icobrain mr), Standard of Care (SOC)
- Keywords
- Multiple Sclerosis, Quantitative Brain MRI, icobrain mr, Neurodegeneration, Disease activity, Disease worsening
- 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.
quantitative brain MRI (icobrain mr)Device
Quantitative brain MRI refers to using a specialised software to compute volumes of brain structures and of MS lesions from brain MRI scans, and to measures differences between a previous brain MRI scan and the current brain MRI scan.
The quantitative brain MRI solution being investigated in the PROCLAIM study is icobrain mr, a software solution that uses artificial intelligence (AI) to help with tracking of MS disease progression by measuring brain structures and lesions on magnetic resonance imaging (MRI).
Standard of Care (SOC)Other
Standard of Care practices at each participating site for management of multiple sclerosis.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of Care practices at each participating site will be employed. Participants in the control arm will receive care according to the usual procedures of the site, without icobrain mr analysis being provided to the participating site during the main study period. Receives: Other: Standard of Care (SOC) |
| Standard of Care with quantitative brain MRI (icobrain mr) | Experimental | Participants in the intervention arm will receive care according to the usual procedures of the participating sites and will have their brain MRI scans analysed using the icobrain mr software. icobrain mr results for each participant will be provided to the participating site prior to the regular clinic visit during the study period. Receives: Device: quantitative brain MRI (icobrain mr); Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of using icobrain mr on detecting (inflammatory or smouldering) disease activity
The difference between control arm and interventional arm in the proportion of patients for whom disease activity or progression is reported by the neurologist at baseline.
Measured: baseline
Impact of using icobrain mr on the clinical outcome
The difference between control arm and interventional arm in the number of patients with no disease activity or progression at month 24.
Measured: month 24
Secondary outcomes (18)
Proportion of patients who switch treatment
Difference between control arm and interventional arm in the proportion of patients who switch their treatment due to detection of disease activity at baseline.
Measured: baseline
Objective of each treatment switch
Descriptive analysis of the type and reason of treatment switches.
Measured: baseline
Role of disease activity on MRI in the decision to make a treatment switch
Difference between control arm and interventional arm in the proportion of patients who switch their treatment due to disease activity on MRI.
Measured: baseline
Role of quantitative brain MRI in the decision to make a treatment switch
Number of treatment switches in the interventional arm in which quantitative brain MRI played a role in the clinical decision-making process to switch DMT.
Measured: baseline
Neurologist confidence in the clinical decision-making process (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident)
Difference between control and interventional arm in the average confidence of the neurologist in the clinical decision-making process at baseline.
Measured: baseline
Neurologist confidence in confirming the diagnosis of MS (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident)
Difference between control and interventional arm in the average confidence of the neurologist in confirming diagnosis of MS at baseline.
Measured: baseline
Neurologist confidence in confirming the conversion to SPMS (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident)
Difference between control and interventional arm in the average confidence of the neurologist in confirming conversion to SPMS at baseline.
Measured: baseline
Proportion of patients with detected smouldering or inflammatory disease components
The difference between control arm and interventional arm in the proportion of patients for whom smouldering or inflammatory disease components are reported by the neurologist at baseline.
Measured: baseline
Reported MRI findings at baseline
Difference between control arm and interventional arm in the number of reported MRI findings at baseline, among:
- new FLAIR lesions
- enlarging FLAIR lesions
- total FLAIR lesion volume
- T1 hypointense lesions
- T1 hyperintense lesions (if T1-post available)
- whole brain volume loss
- gray matter volume loss
- central vein sign lesions (if SWI available)
- paramagnetic rim lesions (if SWI available)
- (cervical) spinal cord atrophy (if assessable)
Measured: baseline
Proportion of patients with relapse associated worsening (RAW)
The difference between control arm and interventional arm in the proportion of patients for whom RAW disease activity or progression is reported by the neurologist at month 12 to month 24.
Measured: month 12 - month 24
Proportion of patients with smouldering associated worsening (SAW)
The difference between control arm and interventional arm in the proportion of patients for whom SAW disease activity or progression is reported by the neurologist at month 12 to month 24.
Measured: month 12 - month 24
Proportion of relapse-free participants between month 12 and month 24
Difference between control arm and interventional arm in the proportion of relapse-free participants between month 12 and month 24.
Measured: month 12 - month 24
Relapse rate between month 12 and month 24
Difference between control arm and interventional arm in the (baseline-adjusted) relapse rate between month 12 and month 24.
Measured: month 12 - month 24
Proportion of participants with EDSS progression between month 12 and 24
Difference between control arm and interventional arm in the proportion of participants with EDSS progression
Measured: month 12 - month 24
Change in clinical score Nine Hole Peg Test (9HPT) between month 12 and 24
Difference between control arm and interventional arm in clinical score 9HPT change between month 12 and 24
Measured: month 12 - month 24
Change in clinical score Timed 25-Foot Walk (T25WT) between month 12 and 24
Difference between control arm and interventional arm in T25WT change between month 12 and 24
Measured: month 12 - month 24
Change in clinical score Symbol Digit Modalities Test (SDMT) between month 12 and 24
Difference between control arm and interventional arm in SDMT change between month 12 and 24
Measured: month 12 - month 24
MRI findings as assessed by icobrain mr in combination with the radiologist at month 24
Difference between control arm and interventional arm in the MRI findings as assessed by icobrain mr in combination with the radiologist from month 12 and month 24.
Measured: month 12 - month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start9 Oct 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- icometrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ruhr University of Bochum, Technische Universität Dresden, Casa di Cura IGEA, General University Hospital, Prague, Charite University, Berlin, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032246
- Sponsor's protocol ID
- ICO-S-003
- Acronym
- PROCLAIM
- Status last verified
- Dec 2025
- First submitted
- 2 Jun 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study
- ClinicalTrials.gov ID
- NCT07032246
- Acronym / sponsor ID
- PROCLAIM / ICO-S-003
- Keywords
- Multiple Sclerosis, Quantitative Brain MRI, icobrain mr, Neurodegeneration, Disease activity, Disease worsening
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- icometrixIndustry (pharma, biotech, devices)
- Collaborators
- Ruhr University of Bochum, Technische Universität Dresden, Casa di Cura IGEA, General University Hospital, Prague, Charite University, Berlin, Germany
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 22 Jun 2025 (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 goal of the PROCLAIM study is to assess the effectiveness of quantitative brain MRI, as measured by icobrain mr, on the detection of disease activity in multiple sclerosis, including the identification of smouldering disease, and the downstream effects on clinical decision making and patient outcomes in a real-world setting.
The study will compare an intervention arm implementing quantitative brain MRI (using the CE-marked medical device software icobrain mr) as part of Standard of Care, and a control arm implementing Standard of Care without quantitative brain MRI.
Detailed description
PROCLAIM (Clinical Impact through AI-assisted MS care: a prospective multi-centre study) is a prospective multi-country multi-site comparative effectiveness study conducted within the scope of the EU-funded research project "Clinical impact through AI-assisted MS Care" (CLAIMS). Quantitative brain MRI will be implemented in this study based on the icobrain mr medical device. icobrain mr is an AI software solution for brain MRI analysis in multiple sclerosis that provides quantitative measurements on disease activity and progression. icobrain mr is CE-marked as a medical device software Class IIa and will be used in PROCLAIM according to its intended use. The study does not involve procedures additional to those performed under the normal conditions of use of the device, nor any other invasive or burdensome procedures.
The study will assess the impact of using quantitative brain MRI, as measured by icobrain mr, on the quality of care. In particular, the study will evaluate the impact on detecting disease activity in MS, as well as on clinical decision-making and clinical outcomes in routine clinical practice for people with MS (pwMS). The study will target both the inflammatory and smouldering components of the disease using assessments already used in daily clinical routine. Exploratory analyses will focus on the relation to other biomarkers used in clinical routine of the participating sites (optic coherence tomography (OCT), evoked potentials (EPs)), as well as patient reported outcomes and passive monitoring measurements (sleep duration, step count and environmental temperature) collected via the icompanion patient app, in conjunction with clinical and radiological parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of Care (SOC)Standard of Care practices at each participating site will be employed. Participants in the control arm will receive care according to the usual procedures of the site, without icobrain mr analysis being provided to the participating site during the main study period. |
| Standard of Care with quantitative brain MRI (icobrain mr) | Experimental | Device: quantitative brain MRI (icobrain mr), Other: Standard of Care (SOC)Participants in the intervention arm will receive care according to the usual procedures of the participating sites and will have their brain MRI scans analysed using the icobrain mr software. icobrain mr results for each participant will be provided to the participating site prior to the regular clinic visit during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to independently understand, evaluate and sign the informed consent form.
- Able to comply with the study protocol, including having a mobile device capable of running the icompanion app.
- Have a definite diagnosis of MS, confirmed as per revised McDonald 2017 criteria (treated or untreated) and/or a diagnosis of RIS/CIS (following the revised McDonald criteria presented during ECTRIMS 2024)
- Patients early in the disease course of RRMS (CIS/RIS, RRMS with disease duration < 7 years), patients with initial diagnosis of relapsing MS and disease duration 12-18 years (prone to convert to SPMS).
- Clinical and brain MRI data available at least one year prior to the study
Key exclusion criteria (7 listed)
- Unable or unwilling to understand, evaluate and sign the informed consent form.
- Any contraindications for undergoing an MRI.
- Currently involved in another interventional study.
- Currently pregnant or planning a pregnancy in the coming 2 years.
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quantitative brain MRI (icobrain mr)Quantitative brain MRI refers to using a specialised software to compute volumes of brain structures and of MS lesions from brain MRI scans, and to measures differences between a previous brain MRI scan and the current brain MRI scan. The quantitative brain MRI solution being investigated in the PROCLAIM study is icobrain mr, a software solution that uses artificial intelligence (AI) to help with tracking of MS disease progression by measuring brain structures and lesions on magnetic resonance imaging (MRI). | Device | Standard of Care with quantitative brain MRI (icobrain mr) |
| Standard of Care (SOC)Standard of Care practices at each participating site for management of multiple sclerosis. | Other | Standard of Care, Standard of Care with quantitative brain MRI (icobrain mr) |
Primary outcome
Impact of using icobrain mr on detecting (inflammatory or smouldering) disease activity
Time frame: baseline
The difference between control arm and interventional arm in the proportion of patients for whom disease activity or progression is reported by the neurologist at baseline.
Impact of using icobrain mr on the clinical outcome
Time frame: month 24
The difference between control arm and interventional arm in the number of patients with no disease activity or progression at month 24.
18 secondary outcomes
Proportion of patients who switch treatment
Time frame: baseline
Objective of each treatment switch
Time frame: baseline
Role of disease activity on MRI in the decision to make a treatment switch
Time frame: baseline
Role of quantitative brain MRI in the decision to make a treatment switch
Time frame: baseline
Neurologist confidence in the clinical decision-making process (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident)
Time frame: baseline
Neurologist confidence in confirming the diagnosis of MS (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident)
Time frame: baseline
Neurologist confidence in confirming the conversion to SPMS (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident)
Time frame: baseline
Proportion of patients with detected smouldering or inflammatory disease components
Time frame: baseline
Reported MRI findings at baseline
Time frame: baseline
Proportion of patients with relapse associated worsening (RAW)
Time frame: month 12 - month 24
Proportion of patients with smouldering associated worsening (SAW)
Time frame: month 12 - month 24
Proportion of relapse-free participants between month 12 and month 24
Time frame: month 12 - month 24
Relapse rate between month 12 and month 24
Time frame: month 12 - month 24
Proportion of participants with EDSS progression between month 12 and 24
Time frame: month 12 - month 24
Change in clinical score Nine Hole Peg Test (9HPT) between month 12 and 24
Time frame: month 12 - month 24
Change in clinical score Timed 25-Foot Walk (T25WT) between month 12 and 24
Time frame: month 12 - month 24
Change in clinical score Symbol Digit Modalities Test (SDMT) between month 12 and 24
Time frame: month 12 - month 24
MRI findings as assessed by icobrain mr in combination with the radiologist at month 24
Time frame: month 12 - month 24
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 9 Dec 2025.
- Website of the EU-funded CLAIMS project of which this study is a part.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quantitative brain MRI (icobrain mr) in people with Multiple Sclerosis and Radiologically Isolated Syndrome, run by icometrix at 6 sites in 3 countries.
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 6 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Italy, Czechia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of using icobrain mr on detecting (inflammatory or smouldering) disease activity (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2025; AzTrials last refreshed its copy on 3 Nov 2026.