Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes (VISUO-CEREBRO)

June 3, 2021 updated by: Centre Hospitalier Universitaire de Besancon
This study aims at assessing the proportion of patients suffering from neuro-visual troubles (visual-spatial and/or visual-perceptual ), after cerebellar strokes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • CHU de Besançon
        • Contact:
        • Principal Investigator:
          • Eloi MAGNIN, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent form
  • Being able to pass initial neuropsychological tests within 10 days after stroke

Exclusion Criteria:

  • Previous central neural system/psychiatric/eye disease (including severe cranial trauma)
  • Chronic alcoholism
  • MRI contraindication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Additional MRI sequences
Device: Additional MRI sequences
Additional MRI sequences (3D T2 SPACE sequence, 4/5 minutes approximatively)
Other: Neuropsychological assessment
Neurovisual function assessed with neuropsychological tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Neuro-Visual Disorder
Time Frame: Month 3

Presence of neuro-visual disorder will be confirmed by obtaining at least 2 pathological scores at following neuropsychological tests:

  • Rey & Taylor figures (score from 0 to 36, maximum)
  • Judgment of Line Orientation (score from 0 to 36, maximum)
  • Weschler Adult Intelligence Scale (final score is intelligence quotient, with an average score is fixed at 100)
  • Test of Attentional Performance
  • Visual Object and Space Perception Battery (eight tests each designed to assess a particular aspect of object or space perception, while minimising the involvement of other cognitive skills)
  • Visual agnosia assesment protocole (noted on 10 points)
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Eloi MAGNIN, MD, PhD, CHU de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 16, 2020

Primary Completion (ANTICIPATED)

July 1, 2021

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (ACTUAL)

June 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2019/423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe