NCT02893683

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

3.4 years

First QC Date

August 30, 2016

Last Update Submit

February 9, 2018

Conditions

Multiple Sclerosis

Keywords

Paris Visual Learning Testvisual memorycriterion validity

Outcome Measures

Primary Outcomes (1)

  • test score

    baseline

Interventions

Paris Visual Learning TestOTHER

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with multiple sclerosis. The test results will be compared to a database including results of healthy control patients.

You may qualify if:

  • multiple sclerosis
  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anne-Claire VIRET-VILAYPHONH

    Fondation OPH A de Rothschild

    STUDY DIRECTOR

  • Olivier GOUT, MD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 8, 2016

Study Start

December 19, 2013

Primary Completion

May 15, 2017

Study Completion

May 15, 2017

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

FR(1)