Multiple Sclerosisvalid-PVLTNCT02893683
Paris Visual Learning Test: a New French Task for Assess Visual Learning and Memory to Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially memory function. Rothschild Foundation has developped the Paris Visual Learning and memory Test (PVLT). 165 healthy volunteers were studied for its normalization. Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Paris Visual Learning Test
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2013to 15 May 2017
- 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 20 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multiple sclerosis. The test results will be compared to a database including results of healthy control patients.
Who may be able to join
- multiple sclerosis
- 20-89 years old
Who cannot join
- acute inflammatory stage of central nervous system (< 1 month)
- other neurological or psychiatric disease
- regular drug and/or alcohol consumption
- refusal to participate in the study
- no health insurance coverage
- patient under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paris Visual Learning Test (PVLT): a New French Task for Assess Visual Learning and Memory to Multiple Sclerosis Patients
Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially memory function.
Rothschild Foundation has developped the Paris Visual Learning and memory Test (PVLT). 165 healthy volunteers were studied for its normalization.
The main objective of the present study is to assess the validity of PVLT by comparing MS patients' test results to a database including the test results of 280 healthy control subjects, following recommended international standards.
- Conditions
- Multiple Sclerosis
- Being tested
- Paris Visual Learning Test
- Keywords
- Paris Visual Learning Test, visual memory, criterion validity
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paris Visual Learning TestOther
What is being measured
The primary outcome is the main question the study is designed to answer.
test score
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start19 Dec 2013
- Primary completion15 May 2017
- Study completion15 May 2017
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Anne-Claire VIRET-VILAYPHONH, Study director, Fondation OPH A de RothschildOlivier GOUT, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893683
- Sponsor's protocol ID
- OGT_2013-4
- Acronym
- valid-PVLT
- Status last verified
- Feb 2018
- First submitted
- 30 Aug 2016
- Last updated
- 12 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paris Visual Learning Test (PVLT): a New French Task for Assess Visual Learning and Memory to Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT02893683
- Acronym / sponsor ID
- valid-PVLT / OGT_2013-4
- Conditions
- Multiple Sclerosis
- Keywords
- Paris Visual Learning Test, visual memory, criterion validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 19 Dec 2013 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 8 Sep 2016 (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 affects up to 65% of multiple sclerosis (MS) subjects, especially memory function.
Rothschild Foundation has developped the Paris Visual Learning and memory Test (PVLT). 165 healthy volunteers were studied for its normalization.
The main objective of the present study is to assess the validity of PVLT by comparing MS patients' test results to a database including the test results of 280 healthy control subjects, following recommended international standards.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple sclerosis. The test results will be compared to a database including results of healthy control patients.
Key inclusion criteria (2 listed)
- multiple sclerosis
- 20-89 years old
Key exclusion criteria (6 listed)
- acute inflammatory stage of central nervous system (< 1 month)
- other neurological or psychiatric disease
- regular drug and/or alcohol consumption
- refusal to participate in the study
- no health insurance coverage
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 |
|---|---|---|
| Paris Visual Learning Test | Other | – |
Primary outcome
test score
Time frame: baseline
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 12 Feb 2018.
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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.
Anne-Claire VIRET-VILAYPHONH study director
Fondation OPH A de Rothschild
Olivier GOUT, MD principal investigator
Fondation OPH A de Rothschild
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 Fondation Ophtalmologique Adolphe de Rothschild 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 6 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 12 Feb 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?
test score (time frame: baseline). It is what the study was designed to measure, not a finding.
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 12 Feb 2018.