Multiple SclerosisNCT01250665
Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis and Cognitive Impairment, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
This study is a cross sectional study of patients diagnosed with clinically isolated syndrome (CIS) and RRMS, who will undergo a series of tests to assess cognitive impairment, fatigue severity and depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Cognitive Impairment
- How many people
- 65 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Jun 2011
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: MS-Patients will be recruited in the outpatient clinic of the neurology department of the cantonal hospital of Saint Gallen, responsible for treatment of MS patients of Northeast Switzerland.
Who may be able to join
- Patients between 18 and 55 years at presentation
- Diagnosis of relapsing-remitting MS according to revised McDonald criteria 2005, clinically isolated syndrome suggestive of MS
- Patients treated with interferon-beta 1b
- Untreated patients
- EDSS under 5.5
Who cannot join
- Brain pathology other than MS
- Known history of head trauma
- Pure spinal manifestation of demyelization
- Neuromyelitis optica
- Primary and secondary progressive MS
- Benzodiazepine intake within the last three months
Show all 11Show fewer
- Relapse within the last three months
- Steroid intake within the last three months
- History of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse
- No informed consent
- Insufficient knowledge of German
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cantonal Hospital of Saint Gallen
Sankt Gallen, 9007
Murat Yildiz, MD
Stafanie Muller, MD
About this study
Official title: Cohort Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Early and Remitting Relapsing Multiple Sclerosis
This study is a cross sectional study of patients diagnosed with clinically isolated syndrome (CIS) and RRMS, who will undergo a series of tests to assess cognitive impairment, fatigue severity and depressive symptoms. Cognitive impairment will be assessed with Multiple Sclerosis Inventory Cognition (MUSIC) and symbol digit modalities test (SDMT), fatigue severity will be measured with the Fatigue Scale for Motor and Cognitive Functions (FSMC) and depressive symptoms with the Beck Depression Inventory (BDI). All tests mentioned above are validated for MS patients. In the second step we will use our large longitudinal database of serial MRI examinations from which a linear measurement of CCI will be retrospectively calculated.
- Conditions
- Multiple Sclerosis, Cognitive Impairment
- Keywords
- multiple sclerosis, cognitive impairment, interferon-beta 1b, corpus callosum index
- 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 |
|---|---|---|
| clinically isolated syndrome | In this study the term clinically isolated syndrome (CIS) is defined according to the Task Force on Differential Diagnosis in MS, as a monophasic presentation of neurological symptoms with suspected underlying inflammatory demyelinating disease (Miller 2008). | |
| remitting, relapsing MS | remitting relapsing MS according to the criteria by Poser (Poser 1983) or McDonald (McDonald 2001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Inventory Cognition (MUSIC)
MUSIC is a cognitive screening instrument. It assesses the cognitive core deficit in MS (mental flexibility, attention, information processing speed, memory and inhibitory control) and includes 3 items derived from a factorial analysis to examine cognitive, motor and psychosocial fatigue, respectively.
Annual Corpus Callosum Index decrease
Corpus callosum index (CCI) is an easy to use MRI marker for estimating brain atrophy in patients with MS. Demonstrated correlation of CCI and atrophy has been measured with brain parenchymal fraction.
Secondary outcomes (4)
Corpus callosum Index at baseline
The CCI at baseline will be measured from MRI findings acquired at diagnosis of clinically isolated syndrome.
Time to clinically definite MS
This is the time in months then patients diagnosed with CIS go on to develop clinically definite MS (CDMS). CDMS will be diagnosed if patients fulfill the criteria for remitting relapsing MS according to Poser (Poser 1983) or McDonald (McDonald 2001).
The Symbol Digit Modalities Test (SDMT)
SDMT is an easily administered brief cognitive performance tests. This test emphasizes working memory and speed processing.
Ratio treatment duration to disease duration
The ratio of duration of treatment (DT) to duration of disease (DD): DT/DD. Duration of treatment is the cumulative time of treatment with interferon-beta 1b. Duration of disease starts from the first presentation of MS symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
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 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
- Cross-sectional
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Murat Yildiz, MD, Principal investigator, Cantonal Hospital Saint Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250665
- Sponsor's protocol ID
- CogImp01
- Status last verified
- Nov 2010
- First submitted
- 30 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Yildiz M, Tettenborn B, Radue EW, Bendfeldt K, Borgwardt S. Association of cognitive impairment and lesion volumes in multiple sclerosis--a MRI study. Clin Neurol Neurosurg. 2014 Dec;127:54-8. doi: 10.1016/j.clineuro.2014.09.019. Epub 2014 Oct 14.
PubMed 25459243
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Early and Remitting Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01250665
- Acronym / sponsor ID
- CogImp01
- Conditions
- Multiple Sclerosis, Cognitive Impairment
- Keywords
- multiple sclerosis, cognitive impairment, interferon-beta 1b, corpus callosum index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 1 Dec 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.
This study is a cross sectional study of patients diagnosed with clinically isolated syndrome (CIS) and RRMS, who will undergo a series of tests to assess cognitive impairment, fatigue severity and depressive symptoms. Cognitive impairment will be assessed with Multiple Sclerosis Inventory Cognition (MUSIC) and symbol digit modalities test (SDMT), fatigue severity will be measured with the Fatigue Scale for Motor and Cognitive Functions (FSMC) and depressive symptoms with the Beck Depression Inventory (BDI). All tests mentioned above are validated for MS patients. In the second step we will use our large longitudinal database of serial MRI examinations from which a linear measurement of CCI will be retrospectively calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinically isolated syndrome | – | –In this study the term clinically isolated syndrome (CIS) is defined according to the Task Force on Differential Diagnosis in MS, as a monophasic presentation of neurological symptoms with suspected underlying inflammatory demyelinating disease (Miller 2008). |
| remitting, relapsing MS | – | –remitting relapsing MS according to the criteria by Poser (Poser 1983) or McDonald (McDonald 2001) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- MS-Patients will be recruited in the outpatient clinic of the neurology department of the cantonal hospital of Saint Gallen, responsible for treatment of MS patients of Northeast Switzerland.
Key inclusion criteria (5 listed)
- Patients between 18 and 55 years at presentation
- Diagnosis of relapsing-remitting MS according to revised McDonald criteria 2005, clinically isolated syndrome suggestive of MS
- Patients treated with interferon-beta 1b
- Untreated patients
- EDSS under 5.5
Key exclusion criteria (11 listed)
- Brain pathology other than MS
- Known history of head trauma
- Pure spinal manifestation of demyelization
- Neuromyelitis optica
- Primary and secondary progressive MS
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
Multiple Sclerosis Inventory Cognition (MUSIC)
MUSIC is a cognitive screening instrument. It assesses the cognitive core deficit in MS (mental flexibility, attention, information processing speed, memory and inhibitory control) and includes 3 items derived from a factorial analysis to examine cognitive, motor and psychosocial fatigue, respectively.
Annual Corpus Callosum Index decrease
Corpus callosum index (CCI) is an easy to use MRI marker for estimating brain atrophy in patients with MS. Demonstrated correlation of CCI and atrophy has been measured with brain parenchymal fraction.
4 secondary outcomes
Corpus callosum Index at baseline
Time to clinically definite MS
The Symbol Digit Modalities Test (SDMT)
Ratio treatment duration to disease duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
- Derived from this study: PubMed 25459243Yildiz M, Tettenborn B, Radue EW, Bendfeldt K, Borgwardt S. Association of cognitive impairment and lesion volumes in multiple sclerosis--a MRI study. Clin Neurol Neurosurg. 2014 Dec;127:54-8. doi: 10.1016/j.clineuro.2014.09.019. Epub 2014 Oct 14.
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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.
Murat Yildiz, MD principal investigator
Cantonal Hospital Saint Gallen
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 Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Multiple Sclerosis Inventory Cognition (MUSIC). 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?
On the ClinicalTrials.gov record for NCT01250665, 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 1 Dec 2010.