Multiple SclerosisMETACOGSEPNCT04240379
Metacognition Assessment in Patient With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This study will assessed the level of consciousness of MS patients suffering of cognitive and motor disorders. Understanding the awareness of the disease is crucial to allow better management of these patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2020to 8 Apr 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study will be proposed to subject : * Male or female with diagnosis of MS, * admitted in neurological unit for passing the MSFC (Multiple Sclerosis Functionnal Composite) test * who respect selection criteria.
Who may be able to join
- Diagnosis of multiple sclerosis
- Voluntary for participate to study
Who cannot join
- Neurological disease other than Multiple Sclerosis
- psychiatric disease, other than depressiveness
- illicit substance abuse
- Persons referred to in Articles L1121-5 to 8 of the French Public Health Code
Trial locations and contacts
1 site in 1 country.
About this study
This study will assessed the level of consciousness of MS patients suffering of cognitive and motor disorders. Understanding the awareness of the disease is crucial to allow better management of these patients. It has been shown, for other neurological pathologies, that a lack of awareness of deficits leads to inefficient rehabilitation and a disorder of understanding the impact of deficits in daily activities. Metacognition could be altered with age, so we will include participants between 18 and 60 years old.
Read the detailed description
Subject who have to do neurological assessement by the Multiple sclerosis Functional Composite (MSFC) will be enrolled.
The patient will estimate the time to undergo the test. This time will be compared to the time really make by the patient to realise test.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Multiple Sclerosis Functional Composite (MSFC), Metacognition
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Metacognitive precision
Metacognitive precision based on Multiple Sclerosis Functional Composite (MSFC) score
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start11 Jun 2020
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240379
- Sponsor's protocol ID
- 38RC19.146
- Other IDs
- 2019-A01278-49
- Acronym
- METACOGSEP
- Status last verified
- May 2022
- First submitted
- 6 Jan 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calabrese P. Neuropsychology of multiple sclerosis--an overview. J Neurol. 2006 Feb;253 Suppl 1:I10-5. doi: 10.1007/s00415-006-1103-1.
PubMed 16477479Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.
PubMed 19007738Beatty WW, Monson N. Metamemory in multiple sclerosis. J Clin Exp Neuropsychol. 1991 Mar;13(2):309-27. doi: 10.1080/01688639108401046.
PubMed 1688342
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognition Assessment in Patient With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04240379
- Acronym / sponsor ID
- METACOGSEP / 38RC19.146
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Multiple Sclerosis Functional Composite (MSFC), Metacognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 27 Jan 2020 (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.
This study will assessed the level of consciousness of MS patients suffering of cognitive and motor disorders. Understanding the awareness of the disease is crucial to allow better management of these patients. It has been shown, for other neurological pathologies, that a lack of awareness of deficits leads to inefficient rehabilitation and a disorder of understanding the impact of deficits in daily activities. Metacognition could be altered with age, so we will include participants between 18 and 60 years old.
Detailed description
Subject who have to do neurological assessement by the Multiple sclerosis Functional Composite (MSFC) will be enrolled.
The patient will estimate the time to undergo the test. This time will be compared to the time really make by the patient to realise test.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will be proposed to subject : * Male or female with diagnosis of MS, * admitted in neurological unit for passing the MSFC (Multiple Sclerosis Functionnal Composite) test * who respect selection criteria.
Key inclusion criteria (2 listed)
- Diagnosis of multiple sclerosis
- Voluntary for participate to study
Key exclusion criteria (4 listed)
- Neurological disease other than Multiple Sclerosis
- psychiatric disease, other than depressiveness
- illicit substance abuse
- Persons referred to in Articles L1121-5 to 8 of the French Public Health Code
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
Metacognitive precision
Time frame: Day 1
Metacognitive precision based on Multiple Sclerosis Functional Composite (MSFC) score
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 1 Jun 2022.
- Background: PubMed 16477479Calabrese P. Neuropsychology of multiple sclerosis--an overview. J Neurol. 2006 Feb;253 Suppl 1:I10-5. doi: 10.1007/s00415-006-1103-1.
- Background: PubMed 19007738Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.
- Results publication: PubMed 1688342Beatty WW, Monson N. Metamemory in multiple sclerosis. J Clin Exp Neuropsychol. 1991 Mar;13(2):309-27. doi: 10.1080/01688639108401046.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University Hospital, Grenoble 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 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: finished, as of the sponsor's last update on 1 Jun 2022. 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?
Metacognitive precision (time frame: Day 1). 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 NCT04240379, which also lists 3 linked publications.
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 Jun 2022.