Multiple SclerosisNCT05072691
Prognostic Value of Cerebrospinal Fluid Immunoglobulin Free Light Chains in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Francis Corazza at 1 site in Belgium.
Trial summary
Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system, usually presenting as clinically isolated syndrome (CIS). The course of MS following first symptoms is unpredictable, as approximately 30% of patients with MS have a benign course and don't develop significant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- CSF immunoglobulin (Ig) free light chains (FLC) dosage
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jul 2020to 1 Jan 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients with MS and ON * Patients with non-inflammatory neurologic diseases (NIND) and patients with other inflammatory neurologic diseases (IND) as control group
Who may be able to join
- Age ≥ 18 at the time of enrollment
- Diagnosis of multiple sclerosis according to 2017 McDonald diagnostic criteria or optic neuritis (fulfilling or not criteria for multiple sclerosis, i.e. clinically isolated syndrome)
- Receiving both lumbar puncture and brain MRI for the routine diagnostic work-up
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Serena Borrelli, MD, 3224750308, Serena.BORRELLI@chu-brugmann.be
About this study
Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system, usually presenting as clinically isolated syndrome (CIS). The course of MS following first symptoms is unpredictable, as approximately 30% of patients with MS have a benign course and don't develop significant disability while another 20-30% progress to severe disability within a relatively short time period. In this context, it is difficult to counsel an individual patient and choose the best treatment option at time of diagnosis. For these reasons, prognostic markers that could be used to predict future disease course are extremely useful.
The only cerebrospinal fluid (CSF) prognostic biomarker currently used in clinical practice are oligoclonal bands (OCB) that can predict conversion from CIS to clinically definite MS, although this observation is not consistent. However, OCB analyses are qualitative with issues in reproducibility and a limited dynamic range. CSF immunoglobulin (Ig) free light chains (FLC) are a quantitative measure of humoral response in CSF that has showed greater sensitivity and specificity than OCB for confirming diagnosis of MS. Moreover, in few recent studies they seem to have also a prognostic value, predicting conversion from CIS to clinically definite MS and correlating with the Expanded Disability Status Scale (EDSS).
Read more
Optic Neuritis (ON) can be a first clinical relapse of MS and is particularly interesting because it may constitute a suitable clinical model for neuroprotection studies, as visual function can be measured with quantitative methods, including Visual Evoked Potential (VEP) and Optical Coherence Tomography (OCT).
The investigators aim to better explore the utility of CSF Ig FLC as potential prognostic biomarker for MS, and to predict the recovery of visual function after ON, as model of MS relapse.
The investigators will study its potential correlation with MS relapses, with changes in several functional outcome scores, exploring physical disability, fatigue, behavior, cognition, upper and lower extremity function, and with MRI disease activity. For a subgroup of patient, the investigators aim to explore its potential correlation with in vivo measures of demyelination and neuronal and axonal loss after ON, as model of potential recovery after MS relapse. The investigators aim also to compare the prognostic value of Ig FLC with Neurofilament light chain (NfL), a potential prognostic biomarker wider studied in MS.
Read the detailed description
Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system, usually presenting as clinically isolated syndrome (CIS). The course of MS following first symptoms is unpredictable, as approximately 30% of patients with MS have a benign course and don't develop significant disability while another 20-30% progress to severe disability within a relatively short time period. In this context, it is difficult to counsel an individual patient and choose the best treatment option at the time of diagnosis. For these reasons, prognostic markers that could be used to predict future disease course are extremely useful.
The only cerebrospinal fluid (CSF) prognostic biomarker currently used in clinical practice are oligoclonal bands (OCB), that can predict the conversion from CIS to clinically definite MS, although this observation is not consistent. However, OCB analyses are qualitative, with issues in reproducibility and a limited dynamic range.
CSF immunoglobulin (Ig) free light chains (FLC) are a quantitative measure of humoral response in CSF that had shown greater sensitivity and specificity than OCB for confirming diagnosis of MS. Moreover, in few recent studies, they showed to have also a potential prognostic value, predicting conversion from CIS to clinically definite MS and correlating with the Expanded Disability Status Scale (EDSS), a scale widely used in clinical practice as marker of MS disability. However, this scale counts very close to ambulation abilities and poorly correlates with other frequent MS symptoms, such as upper extremity disability, fatigue, cognitive and neuropsychiatric symptoms.
One of the most currently studied biomarkers of disease activity and treatment response in MS, not yet widely available in clinical practice, is represented by Neurofilament light chain (NfL). Elevated CSF and blood concentrations of NfL were found to correlate with an increase in the number of relapses, disability worsening, MRI disease activity, and brain volume loss in MS. Blood NfL was shown to strongly correlate with NfL in the CSF of patients with MS and has been proposed as an easily accessible biomarker of treatment response.
Optic Neuritis (ON) can be a first clinical manifestation of MS and is particularly interesting since it may constitute a suitable clinical model for neuroprotection studies. First, visual function can be measured with quantitative methods, including low-contrast acuity, visual fields, and color discrimination. Secondly, Visual Evoked Potential (VEP) with the evaluation of P100 latency, and Optical Coherence Tomography (OCT) with the evaluation of Ganglion Cell Layer (GCL) and Retinal Nerve Fiber Layer (RNFL) thickness, represent in-vivo measures of demyelination, and neuronal and axonal loss secondary to ON, respectively. The investigators aim to better explore the utility of CSF Ig FLC as potential prognostic biomarker of disease activity, disability worsening, and treatment response in patients with MS, and as potential predictor of visual recovery after ON as model of MS relapse. To investigate the prognostic value of CSF Ig FLC, the investigators evaluate the correlation of CSF Ig FLC at the time of MS diagnosis with clinical relapse, with changes in several functional outcome scores, exploring physical disability, fatigue, behavior, cognition, upper and lower extremity functions, and with MRI disease activity. For a subgroup of patient, the investigators aim to explore the correlation of CSF Ig FLC with in vivo measures of demyelination, neuronal and axonal loss after ON, as model of potential recovery after MS relapse. The investigators aim also to compare the prognostic value of Ig FLC with Neurofilament light chain (NfL) concentrations in CSF and blood.
- Conditions
- Multiple Sclerosis
- Being tested
- CSF immunoglobulin (Ig) free light chains (FLC) dosage
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF immunoglobulin (Ig) free light chains (FLC) dosageDiagnostic test
CSF immunoglobulin (Ig) free light chains (FLC) dosage in the peripheral blood and cerebrospinal fluid.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple sclerosis and Optic Neuritis | Patients ≥ 18 year-old at the time of enrollment, with newly diagnosed multiple sclerosis according to 2017 McDonald diagnostic criteria Patients ≥ 18 year-old at the time of enrollment with first episode of optic neuritis, fulfilling or not (i.e. CIS, clinically isolated syndrome) 2017 McDonald diagnostic criteria for multiple sclerosis Receives: Diagnostic Test: CSF immunoglobulin (Ig) free light chains (FLC) dosage | |
| Patients with non-inflammatory neurologic diseases (NIND) | Patients ≥ 18 year-old with suspected non-inflammatory neurologic diseases (such as Alzheimer disease, intracranial hypertension, etc) receiving routine diagnostic lumbar puncture Receives: Diagnostic Test: CSF immunoglobulin (Ig) free light chains (FLC) dosage | |
| Patients with other inflammatory neurologic diseases (IND) | Patients ≥ 18 year-old with suspected inflammatory neurologic diseases other than multiple sclerosis (such as inflammatory peripheral neuropathies, meningitis, neuromyelitis optica spectrum disorders, etc) receiving routine diagnostic lumbar puncture Receives: Diagnostic Test: CSF immunoglobulin (Ig) free light chains (FLC) dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Disability Status Scale (EDSS)
Ordinal scale of 0.0-10 ("no disability" to "death due to MS"), with higher scores reflecting greater level of disability.
Measured: Change from baseline (time of enrollment) up to 4 years
Fatigue Severity Scale (FSS)
Frequently used nine-item questionnaire for the evaluation of fatigue in patients with MS (10). The FSS score is the mean score of the nine items with a cut-off for fatigue set to ≥ 4.
Measured: Change from baseline (time of enrollment) up to 4 years
Hospital Anxiety and Depression Scale (HADS)
The scale is a 14-item self-report measure with seven items each in the depression and anxiety subscales. Each item was scored on a scale of 0-3, with a total potential score of 21, where a threshold score of 8 or greater on each subscale is considered indicative of clinically significant anxiety or depression.
Measured: Change from baseline (time of enrollment) up to 4 years
Symbol-Digit Modalities Test (SDMT)
The test consists of a series of single digits paired with nine symbols, as a reference key. The patient views a pseudorandomized sequence of these symbols and orally responds with the matching digit. The final score is the number of correct responses within 90 seconds, with higher scores corresponding to faster processing speed.
Measured: Change from baseline (time of enrollment) up to 4 years
Nine Hole Peg Test (NHPT)
Brief, standardized, quantitative test, where the patient picks up nine pegs one at a time as quickly as possible, puts them in nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into a container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The final score is an average of the four trials.
Measured: Change from baseline (time of enrollment) up to 4 years
Timed 25-Foot Walk (T25FW)
Quantitative mobility and leg function performance test where the patient is instructed to walk 25 feet as quickly as possible. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. The score is the average of time for the two completed trials.
Measured: Change from baseline (time of enrollment) up to 4 years
Six Spot Step Test (SSST)
The patient is instructed to walk as quickly as possible from one end to the other of a rectangular field measuring 1 x 5 m, while kicking five cylinder blocks out of five circles marked on the floor. The patient has to do four runs, two for each leg. The total score of the SSST is the mean value of time used for each of the four runs.
Measured: Change from baseline (time of enrollment) up to 4 years
Ambulation Score (AS)
The AS is the measure of the distance the patient is able to walk in meters. The score ranges from 0 (ambulation unrestricted) to 12 (essentially restricted to bed).
Measured: Change from baseline (time of enrollment) up to 4 years
Annualized relapse rate (ARR)
Number of relapses per year from disease onset
Measured: Once a year during the observational period.
MRI data: T2 lesions
T2 lesion load in brain and spinal cord
Measured: Change from baseline (time of enrollment) up to 4 years
MRI data : gadolinium enhancing lesions
Gadolinium enhancing lesions in brain and spinal cord
Measured: Change from baseline (time of enrollment) up to 4 years
P100 latency (VEP)
VEP is a measurement of the electrical signal recorded at the scalp over the occipital cortex in response to light stimulus. The studied VEP contains an initial negative peak (N1), followed by a positive peak (P100). Demyelination of the optic nerve results in increased latency of the P100 waveform, without significant effect on amplitude.
Measured: Change from baseline (time of enrollment) up to 4 years
Visual acuity
Low-contrast letter acuity chart measured by low-contrast Sloan letter chart.
Measured: Change from baseline (time of enrollment) up to 4 years
Visual field
Visual field measured by 30-2 SITA Standard visual field test
Measured: Change from baseline (time of enrollment) up to 4 years
Color discrimination
Color discrimination measured by Ishihara test
Measured: Change from baseline (time of enrollment) up to 4 years
GCL thickness (OCT)
OCT is a technique using light waves to take cross-section pictures of retina. It allows measuring of thickness of different retinal layer. The anterior visual pathways consist of the retinal ganglion cells, whose somas are in the ganglion cell layer (GCL) and axons form the retinal nerve fiber layer (RNFL). Assessment of the RNFL and GCL using OCT potentially allows assessing of axonal and neuronal degeneration.
Measured: Change from baseline (time of enrollment) up to 4 years
RNFL thickness (OCT)
OCT is a technique using light waves to take cross-section pictures of retina. It allows measuring of thickness of different retinal layer. The anterior visual pathways consist of the retinal ganglion cells, whose somas are in the ganglion cell layer (GCL) and axons form the retinal nerve fiber layer (RNFL). Assessment of the RNFL and GCL using OCT potentially allows assessing of axonal and neuronal degeneration.
Measured: Change from baseline (time of enrollment) up to 4 years
immunoglobulin (Ig) free light chains (FLC)
Ig FLC concentrations will be measured using the Freelite Mx (CSF) assay (The Binding Site Group, Bimingham, UK) in the peripheral blood and cerebrospinal fluid.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start14 Jul 2020
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francis Corazza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francis Corazza, Brugmann University Hospital
- Investigators
- Serena Borrelli, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072691
- Sponsor's protocol ID
- CHUB-Neuro-Lab-MS
- Status last verified
- Oct 2025
- First submitted
- 13 Sep 2021
- Last updated
- 6 Oct 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 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Cerebrospinal Fluid Immunoglobulin Free Light Chains in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05072691
- Acronym / sponsor ID
- CHUB-Neuro-Lab-MS
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Francis CorazzaUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 11 Oct 2021 (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.
Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system, usually presenting as clinically isolated syndrome (CIS). The course of MS following first symptoms is unpredictable, as approximately 30% of patients with MS have a benign course and don't develop significant disability while another 20-30% progress to severe disability within a relatively short time period. In this context, it is difficult to counsel an individual patient and choose the best treatment option at time of diagnosis. For these reasons, prognostic markers that could be used to predict future disease course are extremely useful.
The only cerebrospinal fluid (CSF) prognostic biomarker currently used in clinical practice are oligoclonal bands (OCB) that can predict conversion from CIS to clinically definite MS, although this observation is not consistent. However, OCB analyses are qualitative with issues in reproducibility and a limited dynamic range. CSF immunoglobulin (Ig) free light chains (FLC) are a quantitative measure of humoral response in CSF that has showed greater sensitivity and specificity than OCB for confirming diagnosis of MS. Moreover, in few recent studies they seem to have also a prognostic value, predicting conversion from CIS to clinically definite MS and correlating with the Expanded Disability Status Scale (EDSS).
Optic Neuritis (ON) can be a first clinical relapse of MS and is particularly interesting because it may constitute a suitable clinical model for neuroprotection studies, as visual function can be measured with quantitative methods, including Visual Evoked Potential (VEP) and Optical Coherence Tomography (OCT).
The investigators aim to better explore the utility of CSF Ig FLC as potential prognostic biomarker for MS, and to predict the recovery of visual function after ON, as model of MS relapse.
The investigators will study its potential correlation with MS relapses, with changes in several functional outcome scores, exploring physical disability, fatigue, behavior, cognition, upper and lower extremity function, and with MRI disease activity. For a subgroup of patient, the investigators aim to explore its potential correlation with in vivo measures of demyelination and neuronal and axonal loss after ON, as model of potential recovery after MS relapse. The investigators aim also to compare the prognostic value of Ig FLC with Neurofilament light chain (NfL), a potential prognostic biomarker wider studied in MS.
Detailed description
Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system, usually presenting as clinically isolated syndrome (CIS). The course of MS following first symptoms is unpredictable, as approximately 30% of patients with MS have a benign course and don't develop significant disability while another 20-30% progress to severe disability within a relatively short time period. In this context, it is difficult to counsel an individual patient and choose the best treatment option at the time of diagnosis. For these reasons, prognostic markers that could be used to predict future disease course are extremely useful.
The only cerebrospinal fluid (CSF) prognostic biomarker currently used in clinical practice are oligoclonal bands (OCB), that can predict the conversion from CIS to clinically definite MS, although this observation is not consistent. However, OCB analyses are qualitative, with issues in reproducibility and a limited dynamic range.
CSF immunoglobulin (Ig) free light chains (FLC) are a quantitative measure of humoral response in CSF that had shown greater sensitivity and specificity than OCB for confirming diagnosis of MS. Moreover, in few recent studies, they showed to have also a potential prognostic value, predicting conversion from CIS to clinically definite MS and correlating with the Expanded Disability Status Scale (EDSS), a scale widely used in clinical practice as marker of MS disability. However, this scale counts very close to ambulation abilities and poorly correlates with other frequent MS symptoms, such as upper extremity disability, fatigue, cognitive and neuropsychiatric symptoms.
One of the most currently studied biomarkers of disease activity and treatment response in MS, not yet widely available in clinical practice, is represented by Neurofilament light chain (NfL). Elevated CSF and blood concentrations of NfL were found to correlate with an increase in the number of relapses, disability worsening, MRI disease activity, and brain volume loss in MS. Blood NfL was shown to strongly correlate with NfL in the CSF of patients with MS and has been proposed as an easily accessible biomarker of treatment response.
Optic Neuritis (ON) can be a first clinical manifestation of MS and is particularly interesting since it may constitute a suitable clinical model for neuroprotection studies. First, visual function can be measured with quantitative methods, including low-contrast acuity, visual fields, and color discrimination. Secondly, Visual Evoked Potential (VEP) with the evaluation of P100 latency, and Optical Coherence Tomography (OCT) with the evaluation of Ganglion Cell Layer (GCL) and Retinal Nerve Fiber Layer (RNFL) thickness, represent in-vivo measures of demyelination, and neuronal and axonal loss secondary to ON, respectively. The investigators aim to better explore the utility of CSF Ig FLC as potential prognostic biomarker of disease activity, disability worsening, and treatment response in patients with MS, and as potential predictor of visual recovery after ON as model of MS relapse. To investigate the prognostic value of CSF Ig FLC, the investigators evaluate the correlation of CSF Ig FLC at the time of MS diagnosis with clinical relapse, with changes in several functional outcome scores, exploring physical disability, fatigue, behavior, cognition, upper and lower extremity functions, and with MRI disease activity. For a subgroup of patient, the investigators aim to explore the correlation of CSF Ig FLC with in vivo measures of demyelination, neuronal and axonal loss after ON, as model of potential recovery after MS relapse. The investigators aim also to compare the prognostic value of Ig FLC with Neurofilament light chain (NfL) concentrations in CSF and blood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple sclerosis and Optic Neuritis | – | Diagnostic Test: CSF immunoglobulin (Ig) free light chains (FLC) dosagePatients ≥ 18 year-old at the time of enrollment, with newly diagnosed multiple sclerosis according to 2017 McDonald diagnostic criteria Patients ≥ 18 year-old at the time of enrollment with first episode of optic neuritis, fulfilling or not (i.e. CIS, clinically isolated syndrome) 2017 McDonald diagnostic criteria for multiple sclerosis |
| Patients with non-inflammatory neurologic diseases (NIND) | – | Diagnostic Test: CSF immunoglobulin (Ig) free light chains (FLC) dosagePatients ≥ 18 year-old with suspected non-inflammatory neurologic diseases (such as Alzheimer disease, intracranial hypertension, etc) receiving routine diagnostic lumbar puncture |
| Patients with other inflammatory neurologic diseases (IND) | – | Diagnostic Test: CSF immunoglobulin (Ig) free light chains (FLC) dosagePatients ≥ 18 year-old with suspected inflammatory neurologic diseases other than multiple sclerosis (such as inflammatory peripheral neuropathies, meningitis, neuromyelitis optica spectrum disorders, etc) receiving routine diagnostic lumbar puncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with MS and ON * Patients with non-inflammatory neurologic diseases (NIND) and patients with other inflammatory neurologic diseases (IND) as control group
Key inclusion criteria (3 listed)
- Age ≥ 18 at the time of enrollment
- Diagnosis of multiple sclerosis according to 2017 McDonald diagnostic criteria or optic neuritis (fulfilling or not criteria for multiple sclerosis, i.e. clinically isolated syndrome)
- Receiving both lumbar puncture and brain MRI for the routine diagnostic work-up
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CSF immunoglobulin (Ig) free light chains (FLC) dosageCSF immunoglobulin (Ig) free light chains (FLC) dosage in the peripheral blood and cerebrospinal fluid. | Diagnostic test | Patients with Multiple sclerosis and Optic Neuritis, Patients with non-inflammatory neurologic diseases (NIND), Patients with other inflammatory neurologic diseases (IND) |
Primary outcome
Expanded Disability Status Scale (EDSS)
Time frame: Change from baseline (time of enrollment) up to 4 years
Ordinal scale of 0.0-10 ("no disability" to "death due to MS"), with higher scores reflecting greater level of disability.
Fatigue Severity Scale (FSS)
Time frame: Change from baseline (time of enrollment) up to 4 years
Frequently used nine-item questionnaire for the evaluation of fatigue in patients with MS (10). The FSS score is the mean score of the nine items with a cut-off for fatigue set to ≥ 4.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline (time of enrollment) up to 4 years
The scale is a 14-item self-report measure with seven items each in the depression and anxiety subscales. Each item was scored on a scale of 0-3, with a total potential score of 21, where a threshold score of 8 or greater on each subscale is considered indicative of clinically significant anxiety or depression.
Symbol-Digit Modalities Test (SDMT)
Time frame: Change from baseline (time of enrollment) up to 4 years
The test consists of a series of single digits paired with nine symbols, as a reference key. The patient views a pseudorandomized sequence of these symbols and orally responds with the matching digit. The final score is the number of correct responses within 90 seconds, with higher scores corresponding to faster processing speed.
Nine Hole Peg Test (NHPT)
Time frame: Change from baseline (time of enrollment) up to 4 years
Brief, standardized, quantitative test, where the patient picks up nine pegs one at a time as quickly as possible, puts them in nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into a container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The final score is an average of the four trials.
Timed 25-Foot Walk (T25FW)
Time frame: Change from baseline (time of enrollment) up to 4 years
Quantitative mobility and leg function performance test where the patient is instructed to walk 25 feet as quickly as possible. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. The score is the average of time for the two completed trials.
Six Spot Step Test (SSST)
Time frame: Change from baseline (time of enrollment) up to 4 years
The patient is instructed to walk as quickly as possible from one end to the other of a rectangular field measuring 1 x 5 m, while kicking five cylinder blocks out of five circles marked on the floor. The patient has to do four runs, two for each leg. The total score of the SSST is the mean value of time used for each of the four runs.
Ambulation Score (AS)
Time frame: Change from baseline (time of enrollment) up to 4 years
The AS is the measure of the distance the patient is able to walk in meters. The score ranges from 0 (ambulation unrestricted) to 12 (essentially restricted to bed).
Annualized relapse rate (ARR)
Time frame: Once a year during the observational period.
Number of relapses per year from disease onset
MRI data: T2 lesions
Time frame: Change from baseline (time of enrollment) up to 4 years
T2 lesion load in brain and spinal cord
MRI data : gadolinium enhancing lesions
Time frame: Change from baseline (time of enrollment) up to 4 years
Gadolinium enhancing lesions in brain and spinal cord
P100 latency (VEP)
Time frame: Change from baseline (time of enrollment) up to 4 years
VEP is a measurement of the electrical signal recorded at the scalp over the occipital cortex in response to light stimulus. The studied VEP contains an initial negative peak (N1), followed by a positive peak (P100). Demyelination of the optic nerve results in increased latency of the P100 waveform, without significant effect on amplitude.
Visual acuity
Time frame: Change from baseline (time of enrollment) up to 4 years
Low-contrast letter acuity chart measured by low-contrast Sloan letter chart.
Visual field
Time frame: Change from baseline (time of enrollment) up to 4 years
Visual field measured by 30-2 SITA Standard visual field test
Color discrimination
Time frame: Change from baseline (time of enrollment) up to 4 years
Color discrimination measured by Ishihara test
GCL thickness (OCT)
Time frame: Change from baseline (time of enrollment) up to 4 years
OCT is a technique using light waves to take cross-section pictures of retina. It allows measuring of thickness of different retinal layer. The anterior visual pathways consist of the retinal ganglion cells, whose somas are in the ganglion cell layer (GCL) and axons form the retinal nerve fiber layer (RNFL). Assessment of the RNFL and GCL using OCT potentially allows assessing of axonal and neuronal degeneration.
RNFL thickness (OCT)
Time frame: Change from baseline (time of enrollment) up to 4 years
OCT is a technique using light waves to take cross-section pictures of retina. It allows measuring of thickness of different retinal layer. The anterior visual pathways consist of the retinal ganglion cells, whose somas are in the ganglion cell layer (GCL) and axons form the retinal nerve fiber layer (RNFL). Assessment of the RNFL and GCL using OCT potentially allows assessing of axonal and neuronal degeneration.
immunoglobulin (Ig) free light chains (FLC)
Time frame: Baseline
Ig FLC concentrations will be measured using the Freelite Mx (CSF) assay (The Binding Site Group, Bimingham, UK) in the peripheral blood and cerebrospinal fluid.
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 6 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Serena Borrelli principal investigator
CHU Brugmann
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 Francis Corazza at 1 site in Belgium.
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 1 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 6 Oct 2025. 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 Belgium. 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 Serena Borrelli, MD (3224750308, Serena.BORRELLI@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded Disability Status Scale (EDSS) (time frame: Change from baseline (time of enrollment) up to 4 years). The study lists 18 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 6 Oct 2025.