Clinically Isolated Demyelinating SyndromesSCI-COGNCT01865357
Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI
A study testing Brain MRI - Clinical and cognitive evaluation and Eye movement in people with Clinically Isolated Demyelinating Syndromes and Multiple Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinically Isolated Demyelinating Syndromes, Multiple Sclerosis, Cognitive Deficiencies
- What is being tested?
- Brain MRI - Clinical and cognitive evaluation and Eye movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 24 Aug 2012to 1 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- Men and Women
- ≥16 years
- Fluent French speaker
- Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation
- Between 60 and 180 days from the onset
Show all 15Show fewer
- At least two clinically silent lesions on their T2-weighted brain or spinal MRI scan with a size of at least 3 mm, at least one of which being cerebral, ovoid, or periventricular
- Having a medical insurance
- Free and informed consent signed
- Controls:
- Men and Women
- ≥18 years
- Fluent French speaker
- Having a medical insurance
- Free and informed consent signed
Who cannot join
- Patients:
- Prior documented neurological episode suggestive of MS.
- Other ongoing neurological diseases.
- Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, sclerodermia, Crohn disease,…).
- Other causes (trauma, tumor, radiotherapy, infections, vascular diseases, neuromyelitis optica).
- Current dependence on alcohol or drugs.
Show all 20Show fewer
- Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 15 days
- MRI contra-indications.
- Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
- Controls:
- Known chronic psychiatric or neurologic diseases which could interfere with neuropsychological testing, not taking into account stable and mild depressive syndrome
- Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, scleroderma, Crohn disease…).
- MS familial history
- Current dependence on alcohol or drugs
- Known cognitive impairment
- Prior neuropsychological testing with the same tests less than one year
- Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 2 months
- Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
- MRI contra-indications
- Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI:"SCI-COG" Study
Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.
Read the detailed description
This is a prospective cohort, observational, longitudinal, monocentric study. This study will include 60 patients with CIS followed for 1 year and 60 healthy subjects.
- Conditions
- Clinically Isolated Demyelinating Syndromes, Multiple Sclerosis, Cognitive Deficiencies, Brain MRI
- Being tested
- Brain MRI - Clinical and cognitive evaluation, Eye movement
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRI - Clinical and cognitive evaluationOther
- Clinical evaluation (EDSS, MSFC)
- Cognitive evaluation with tests of information processing speed, attention, working memory, episodic memory and executive functions, assessment of confounding factors (depression (BDI) and anxiety (HAD), mood (EHD), fatigue (M-FIS) and assessment of quality of life (SEP-59)
- Brain MRI (3 Tesla): FLAIR, 3D MPRAGE T1 and DTI
Eye movementOther
Assessment of eye Movements (EyeBrain software) for only the group of 15 healthy subjects at baseline and at 12 months
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation Receives: Other: Brain MRI - Clinical and cognitive evaluation; Other: Eye movement |
| Control | Experimental | healthy subject Receives: Other: Brain MRI - Clinical and cognitive evaluation; Other: Eye movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between fractional anisotropy (FA) value and cognitive z scores or cognitive impairment indexes for each domains
IPS, attention, working memory, episodic memory and executive functions), established by voxel-wise statistics (TBSS) in CIS patients
Measured: visit 2 - 1 year after inclusion
Secondary outcomes (6)
Comparison of skeleton of FA between CIS patients and healthy subjects
Measured: V2 - 1 year after the inclusion
Comparison of cognitive scores at each test between CIS patients and controls
Measured: D0 and V2 - 1 year after the inclusion
Proportion of patients with cognitive impairment (≥ 3 tests impaired) and correlations with anxiety, depressive syndrome and fatigue
Measured: D0 and V2 - 1 year after the inclusion
Comparison of statistical maps of FA
mean cortical thickness and deep grey nuclei volumes with cognitive indexes in the 3 pre-define groups: cognitively preserved CIS patients at baseline and after one year; cognitively impaired CIS patients only after one year and cognitively impaired CIS patients at the two evaluations.
Measured: D0 and V2 - 1 year after the inclusion
Correlations between cognitive scores and mean cortical thickness and deep grey nuclei volumes in CIS patients
Measured: D0 and V2 - 1 year after the inclusion
Comparison of cognitive scores at each test and eye movements scores
Measured: D0 and V2 - 1 year after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study start24 Aug 2012
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinically Isolated Demyelinating SyndromesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- TEVA laboratories
- Responsible party
- Sponsor
- Investigators
- Bruno BROCHET, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865357
- Sponsor's protocol ID
- CHUBX 2011/33
- Acronym
- SCI-COG
- Status last verified
- Oct 2018
- First submitted
- 24 May 2013
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, Deloire M, Coupe P, Ouallet JC, Planche V, Moscufo N, Meier DS, Tourdias T, Guttmann CR, Dousset V, Brochet B. Posterior lobules of the cerebellum and information processing speed at various stages of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):146-151. doi: 10.1136/jnnp-2016-313867. Epub 2016 Oct 27.
PubMed 27789541
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI:"SCI-COG" Study
- ClinicalTrials.gov ID
- NCT01865357
- Acronym / sponsor ID
- SCI-COG / CHUBX 2011/33
- Conditions
- Clinically Isolated Demyelinating Syndromes, Multiple Sclerosis, Cognitive Deficiencies, Brain MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- TEVA laboratories
- Study start
- 24 Aug 2012 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 30 May 2013 (estimated)
- 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.
Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.
Detailed description
This is a prospective cohort, observational, longitudinal, monocentric study. This study will include 60 patients with CIS followed for 1 year and 60 healthy subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Other: Brain MRI - Clinical and cognitive evaluation, Other: Eye movementClinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation |
| Control | Experimental | Other: Brain MRI - Clinical and cognitive evaluation, Other: Eye movementhealthy subject |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients:
- Controls:
Key exclusion criteria (20 listed)
- Patients:
- Controls:
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 |
|---|---|---|
| Brain MRI - Clinical and cognitive evaluation* Clinical evaluation (EDSS, MSFC) * Cognitive evaluation with tests of information processing speed, attention, working memory, episodic memory and executive functions, assessment of confounding factors (depression (BDI) and anxiety (HAD), mood (EHD), fatigue (M-FIS) and assessment of quality of life (SEP-59) * Brain MRI (3 Tesla): FLAIR, 3D MPRAGE T1 and DTI | Other | Control, Patient |
| Eye movementAssessment of eye Movements (EyeBrain software) for only the group of 15 healthy subjects at baseline and at 12 months | Other | Control, Patient |
Primary outcome
Correlation between fractional anisotropy (FA) value and cognitive z scores or cognitive impairment indexes for each domains
Time frame: visit 2 - 1 year after inclusion
IPS, attention, working memory, episodic memory and executive functions), established by voxel-wise statistics (TBSS) in CIS patients
6 secondary outcomes
Comparison of skeleton of FA between CIS patients and healthy subjects
Time frame: V2 - 1 year after the inclusion
Comparison of cognitive scores at each test between CIS patients and controls
Time frame: D0 and V2 - 1 year after the inclusion
Proportion of patients with cognitive impairment (≥ 3 tests impaired) and correlations with anxiety, depressive syndrome and fatigue
Time frame: D0 and V2 - 1 year after the inclusion
Comparison of statistical maps of FA
Time frame: D0 and V2 - 1 year after the inclusion
Correlations between cognitive scores and mean cortical thickness and deep grey nuclei volumes in CIS patients
Time frame: D0 and V2 - 1 year after the inclusion
Comparison of cognitive scores at each test and eye movements scores
Time frame: D0 and V2 - 1 year after the inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Derived from this study: PubMed 27789541Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, Deloire M, Coupe P, Ouallet JC, Planche V, Moscufo N, Meier DS, Tourdias T, Guttmann CR, Dousset V, Brochet B. Posterior lobules of the cerebellum and information processing speed at various stages of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):146-151. doi: 10.1136/jnnp-2016-313867. Epub 2016 Oct 27.
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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. This study is not recruiting at the moment.
Bruno BROCHET, Prof principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRI - Clinical and cognitive evaluation and Eye movement in people with Clinically Isolated Demyelinating Syndromes and Multiple Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
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 15 inclusion and 20 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: finished, as of the sponsor's last update on 3 Oct 2018. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between fractional anisotropy (FA) value and cognitive z scores or cognitive impairment indexes for each domains (time frame: visit 2 - 1 year after inclusion). 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 NCT01865357, which also lists 1 linked publication.
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 3 Oct 2018.