Multiple SclerosisNCT00423111
Correlation Between Cognitive Functions and MRI in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether there is a correlation between cognitive functions and volume of specific brain area measured in MRI of multiple sclerosis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2007to Feb 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Multiple Sclerosis
- Age 18-65
Who cannot join
- Another brain disease
- Stroke
- Brain trauma
- Neurosurgery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether there is a correlation between cognitive functions and volume of specific brain area measured in MRI of multiple sclerosis patients.
Read the detailed description
Recent literature suggests that multiple sclerosis is accompanied by significant deficits in cognitive performance. The origin of these cognitive deficits is not known, since the severity of cognitive deficits was not found to be correlated with disease parameters such as duration, lesion load or disease intensity as measured on standard scales (e.g. EDSS). The research hypothesis we plan to test is that the individual intensity of cognitive deficits is correlated with degeneration of specific neuronal structures related to cognitive performance, such as the hippocampus and prefrontal cortex.
To test this hypothesis, we plan to perform volumetric measurements of such regions on MRI scans obtained from MS patients during the course of their clinical evaluation, and attempt to correlate those with the results of neuropsychological tests performed by the same subjects around the time of MRI scanning.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Memory, Cognitive deficits, MRI, Hippocampus, Prefrontal cortex
- Medical subject headings
- Multiple Sclerosis, Cognition Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startFeb 2007
- Study completionFeb 2009 (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
- Natural history
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Anat Achiron, MD Ph.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423111
- Sponsor's protocol ID
- SHEBA-06-4487-AA-CTIL
- Status last verified
- Sep 2007
- First submitted
- 15 Jan 2007
- Last updated
- 21 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Cognitive Functions and MRI in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00423111
- Acronym / sponsor ID
- SHEBA-06-4487-AA-CTIL
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Memory, Cognitive deficits, MRI, Hippocampus, Prefrontal cortex
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Feb 2007
- Study completion
- Feb 2009 (estimated)
- First posted
- 17 Jan 2007 (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.
The purpose of this study is to determine whether there is a correlation between cognitive functions and volume of specific brain area measured in MRI of multiple sclerosis patients.
Detailed description
Recent literature suggests that multiple sclerosis is accompanied by significant deficits in cognitive performance. The origin of these cognitive deficits is not known, since the severity of cognitive deficits was not found to be correlated with disease parameters such as duration, lesion load or disease intensity as measured on standard scales (e.g. EDSS). The research hypothesis we plan to test is that the individual intensity of cognitive deficits is correlated with degeneration of specific neuronal structures related to cognitive performance, such as the hippocampus and prefrontal cortex.
To test this hypothesis, we plan to perform volumetric measurements of such regions on MRI scans obtained from MS patients during the course of their clinical evaluation, and attempt to correlate those with the results of neuropsychological tests performed by the same subjects around the time of MRI scanning.
Study design
- Observational model
- Natural history
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Multiple Sclerosis
- Age 18-65
Key exclusion criteria (4 listed)
- Another brain disease
- Stroke
- Brain trauma
- Neurosurgery
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2007.
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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.
Anat Achiron, MD Ph.D principal investigator
Sheba Medical Center
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 Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 4 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 21 Sep 2007. 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 Israel. 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?
Contact Yael Deri, BSc (972 508273381, yaelderi@gmail.com), or a site near the patient. 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 21 Sep 2007.