Multiple SclerosisCogniSEPNCT01157728
Early Cognitive Impairment in Multiple Sclerosis
An observational study of Multiple Sclerosis and Cognitive Impairment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Cognitive impairment is one of the symptoms of Multiple Sclerosis (MS), and it may occur during the first years of the disease. It usually affects attention, information processing speed and short term memory. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Cognitive Impairment
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Dec 2010
- Phase
- Observational
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Relapsing remitting Multiple Sclerosis patients * Age: 18-40 years * Evolving between 3 and 5 years * EDSS<5
Who may be able to join
- Relapsing remitting Multiple Sclerosis patients
- Age: 18-40 years
- Evolving between 3 and 5 years
- EDSS<5
Who cannot join
- MRI exclusion criteria (metallic prothetic, pace maker etc)
- Renal failure due to Gadolinium injection
- Major depressive disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Cognitive Impairment in Multiple Sclerosis: a Multimodal MRI Study Evaluating the Relative Contribution of Cortical and White Matter Tract Injury
Cognitive impairment is one of the symptoms of Multiple Sclerosis (MS), and it may occur during the first years of the disease. It usually affects attention, information processing speed and short term memory. To date, the mechanisms of this specific symptom remain unclear (local or global inflammation, neurodegenerative processes).
Magnetic Resonance Imaging (MRI) can be useful to understand the pathophysiology of cognitive impairment in MS. The investigators will combine conventional and non conventional MRI sequences to determine the respective role of white matter and grey matter injury and the cortical reorganization of neuronal networks.
Read the detailed description
Cognitive impairment in Multiple Sclerosis (MS) occurs in 50% of patients and has a major social impact. There is no clear correlation between cognitive dysfunction and disease duration and recent studies have pointed out that it may affects patients at the very early stages of the disease especially in tasks involving sustained attention, processing speed, working memory and executive function.
Recent imaging and pathology studies have shown that MS affects white matter as well as grey matter. Unlike white matter lesion burden or distribution, grey matter atrophy has often been linked to cognitive impairment. Microscopic injury of Normally Appearing White Matter (NAWM) explored by non conventional MRI sequences has also been shown to be involved in pathophysiology of cognitive disorders.
Nevertheless mechanisms of cognitive impairment remain unclear. The relationship between cortical injury and diffuse white matter tracts damage and their respective contribution to cognitive dysfunction affecting patients during the first years of the disease is still under investigation.
This study aims at investigating structural and functional correlates of early cognitive impairment using multimodal MRI.
Relapsing Remitting MS (RRMS) patients with disease duration of less than 5 years will be included. Patients with and without cognitive impairment will be compared to healthy controls. All subjects will perform a clinical and neuropsychological evaluation before the MRI examination.
We will combine new available MRI techniques using a 3 Tesla magnet in order to evaluate precisely cortical and white matter tracts lesions in patients with cognitive MS. These techniques will include :
- 3D T1 sequences to study cortical atrophy using VBM.
- Diffusion tensor imaging fibre tracking to study selected white matter tracts that may be involved in cognitive disorders, such as the thalamus-cortical or the striatum-cortical tracts connecting sub-cortical structures to the prefrontal cortex.
- Functional MRI sequences during a working memory task and during the resting state in order to describe functional networks and their possible reorganization in patients with or without cognitive impairment.
- Conditions
- Multiple Sclerosis, Cognitive Impairment
- Keywords
- Multiple sclerosis, Cognitive impairment
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
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 |
|---|---|---|
| Relapsing Multiple Sclerosis patients | Not described | |
| healthy volunteer | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startMay 2008
- Primary completionDec 2010
- Study completionDec 2010
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ARSEP (Association pour la Recherche sur la Sclerose en Plaques), JNLF (Journées de Neurologie de Langue Française)
- Responsible party
- Sponsor
- Investigators
- Bruno Stankoff, MD,PhD, Principal investigator, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157728
- Sponsor's protocol ID
- P071102
- Acronym
- CogniSEP
- Status last verified
- May 2010
- First submitted
- 6 Jul 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Cognitive Impairment in Multiple Sclerosis: a Multimodal MRI Study Evaluating the Relative Contribution of Cortical and White Matter Tract Injury
- ClinicalTrials.gov ID
- NCT01157728
- Acronym / sponsor ID
- CogniSEP / P071102
- Conditions
- Multiple Sclerosis, Cognitive Impairment
- Keywords
- Multiple sclerosis, Cognitive impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ARSEP (Association pour la Recherche sur la Sclerose en Plaques), JNLF (Journées de Neurologie de Langue Française)
- Study start
- May 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Jul 2010 (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.
Cognitive impairment is one of the symptoms of Multiple Sclerosis (MS), and it may occur during the first years of the disease. It usually affects attention, information processing speed and short term memory. To date, the mechanisms of this specific symptom remain unclear (local or global inflammation, neurodegenerative processes).
Magnetic Resonance Imaging (MRI) can be useful to understand the pathophysiology of cognitive impairment in MS. The investigators will combine conventional and non conventional MRI sequences to determine the respective role of white matter and grey matter injury and the cortical reorganization of neuronal networks.
Detailed description
Cognitive impairment in Multiple Sclerosis (MS) occurs in 50% of patients and has a major social impact. There is no clear correlation between cognitive dysfunction and disease duration and recent studies have pointed out that it may affects patients at the very early stages of the disease especially in tasks involving sustained attention, processing speed, working memory and executive function.
Recent imaging and pathology studies have shown that MS affects white matter as well as grey matter. Unlike white matter lesion burden or distribution, grey matter atrophy has often been linked to cognitive impairment. Microscopic injury of Normally Appearing White Matter (NAWM) explored by non conventional MRI sequences has also been shown to be involved in pathophysiology of cognitive disorders.
Nevertheless mechanisms of cognitive impairment remain unclear. The relationship between cortical injury and diffuse white matter tracts damage and their respective contribution to cognitive dysfunction affecting patients during the first years of the disease is still under investigation.
This study aims at investigating structural and functional correlates of early cognitive impairment using multimodal MRI.
Relapsing Remitting MS (RRMS) patients with disease duration of less than 5 years will be included. Patients with and without cognitive impairment will be compared to healthy controls. All subjects will perform a clinical and neuropsychological evaluation before the MRI examination.
We will combine new available MRI techniques using a 3 Tesla magnet in order to evaluate precisely cortical and white matter tracts lesions in patients with cognitive MS. These techniques will include :
- 3D T1 sequences to study cortical atrophy using VBM.
- Diffusion tensor imaging fibre tracking to study selected white matter tracts that may be involved in cognitive disorders, such as the thalamus-cortical or the striatum-cortical tracts connecting sub-cortical structures to the prefrontal cortex.
- Functional MRI sequences during a working memory task and during the resting state in order to describe functional networks and their possible reorganization in patients with or without cognitive impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relapsing Multiple Sclerosis patients | – | – |
| healthy volunteer | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Relapsing remitting Multiple Sclerosis patients * Age: 18-40 years * Evolving between 3 and 5 years * EDSS<5
Key inclusion criteria (4 listed)
- Relapsing remitting Multiple Sclerosis patients
- Age: 18-40 years
- Evolving between 3 and 5 years
- EDSS<5
Key exclusion criteria (3 listed)
- MRI exclusion criteria (metallic prothetic, pace maker etc)
- Renal failure due to Gadolinium injection
- Major depressive disorder
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
Not reported in the source record.
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 31 Jul 2012.
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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 Stankoff, MD,PhD principal investigator
Pitié-Salpêtrière Hospital
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 and Cognitive Impairment, run by Assistance Publique - Hôpitaux de Paris 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 4 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: finished, as of the sponsor's last update on 31 Jul 2012. 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.
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 31 Jul 2012; AzTrials last refreshed its copy on 29 Oct 2026.